83 FR 4139 - Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4139-4141
FR Document		2018-01638

The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4139-4141]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2017-N-6285]


Medical Devices; Cardiovascular Devices; Classification of the 
Temporary Catheter for Embolic Protection During Transcatheter 
Intracardiac Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the temporary catheter for embolic protection during transcatheter 
intracardiac procedures into class II (special controls). The special 
controls that apply to the device type are identified in this order and 
will be part of the codified language for the temporary catheter for 
embolic protection during transcatheter intracardiac procedures' 
classification. We are taking this action because we have determined 
that classifying the device into class II (special controls) will 
provide a reasonable assurance of safety and effectiveness of the 
device. We believe this action will also enhance patients' access to 
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective January 30, 2018. The classification was 
applicable on June 1, 2017.

FOR FURTHER INFORMATION CONTACT: Sadaf Toor, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1202, Silver Spring, MD 20993-0002, 301-796-6381, 
Sadaf.Toor@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the temporary catheter for embolic 
protection during transcatheter intracardiac procedures as class II 
(special controls), which we have determined will provide a reasonable 
assurance of safety and effectiveness. In addition, we believe this 
action will enhance patients' access to beneficial innovation, in part 
by reducing regulatory burdens by placing the device into a lower 
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act and 
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.

[[Page 4140]]

    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the less-burdensome 510(k) 
process, when necessary, to market their device.

II. De Novo Classification

    On September 20, 2016, Claret Medical, Inc., submitted a request 
for De Novo classification of the Sentinel[supreg] Cerebral Protection 
System. FDA reviewed the request in order to classify the device under 
the criteria for classification set forth in section 513(a)(1) of the 
FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on June 1, 2017, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 870.1251. We have named 
the generic type of device temporary catheter for embolic protection 
during transcatheter intracardiac procedures, and it is identified as a 
single use percutaneous catheter system that has (a) blood filter(s) at 
the distal end. This device is indicated for use while performing 
transcatheter intracardiac procedures. The device is used to filter 
blood in a manner that may prevent embolic material (thrombus/debris) 
from the transcatheter intracardiac procedure from traveling towards 
the cerebral circulation.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

 Table 1--Temporary Catheter for Embolic Protection During Transcatheter
          Intracardiac Procedures Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Device failure leading to debris         Non-clinical performance
 embolization and stroke or death.        testing, Animal testing, and
                                          Clinical performance testing.
Impeded or disrupted blood flow leading  Non-clinical performance
 to peripheral ischemia.                  testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
Device incompatibility with              Non-clinical performance
 transcatheter intracardiac procedure     testing, Animal testing,
 device leading to prolonged treatment    Clinical performance testing,
 time or device failure.                  and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Vascular injury due to device delivery,  Non-clinical performance
 deployment, placement, or retrieval.     testing, Animal testing,
                                          Clinical performance testing,
                                          and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in part 814, subparts 
A through E, regarding premarket approval, have been approved under OMB 
control number 0910-0231; the collections of information in part 807, 
subpart E, regarding premarket notification submissions, have been 
approved under OMB control number 0910-0120; and the collections of 
information in 21 CFR part 801, regarding labeling, have been approved 
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.1251 to subpart B to read as follows:

[[Page 4141]]

Sec.  870.1251  Temporary catheter for embolic protection during 
transcatheter intracardiac procedures.

    (a) Identification. This device is a single use percutaneous 
catheter system that has (a) blood filter(s) at the distal end. This 
device is indicated for use while performing transcatheter intracardiac 
procedures. The device is used to filter blood in a manner that may 
prevent embolic material (thrombus/debris) from the transcatheter 
intracardiac procedure from traveling towards the cerebral circulation.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be tested:
    (i) Simulated-use testing in a clinically relevant bench anatomic 
model to assess the following:
    (A) Delivery, deployment, and retrieval, including quantifying 
deployment and retrieval forces, and procedural time; and
    (B) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (ii) Tensile strengths of joints and components, tip flexibility, 
torque strength, torque response, and kink resistance.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Characterization and verification of all dimensions.
    (2) Animal testing must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be assessed:
    (i) Delivery, deployment, and retrieval, including quantifying 
procedural time.
    (ii) Device compatibility and lack of interference with the 
transcatheter intracardiac procedure and device.
    (iii) Flow characteristics.
    (A) The ability of the filter to not impede blood flow.
    (B) The amount of time the filter can be deployed in position and/
or retrieved from its location without disrupting blood flow.
    (iv) Gross pathology and histopathology assessing vascular injury 
and downstream embolization.
    (3) All patient contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must demonstrate the sterility of the device 
components intended to be provided sterile.
    (5) Performance data must support the shelf life of the device by 
demonstrating continued sterility, package integrity, and device 
functionality over the identified shelf life.
    (6) Labeling for the device must include:
    (i) Instructions for use;
    (ii) Compatible transcatheter intracardiac procedure devices;
    (iii) A detailed summary of the clinical testing conducted; and
    (iv) A shelf life and storage conditions.
    (7) Clinical performance testing must demonstrate:
    (i) The ability to safely deliver, deploy, and remove the device;
    (ii) The ability of the device to filter embolic material while not 
impeding blood flow;
    (iii) Secure positioning and stability of the position throughout 
the transcatheter intracardiac procedure; and
    (iv) Evaluation of all adverse events including death, stroke, and 
vascular injury.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01638 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P

4140 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations

Under either procedure for De Novo II. De Novo Classification assurance of the safety and effectiveness
classification, FDA is required to On September 20, 2016, Claret of the device.
classify the device by written order Medical, Inc., submitted a request for De Therefore, on June 1, 2017, FDA
within 120 days. The classification will Novo classification of the Sentinel® issued an order to the requester
be according to the criteria under Cerebral Protection System. FDA classifying the device into class II. FDA
section 513(a)(1) of the FD&C Act. reviewed the request in order to classify is codifying the classification of the
Although the device was automatically the device under the criteria for device by adding 21 CFR 870.1251. We
within class III, the De Novo classification set forth in section have named the generic type of device
classification is considered to be the 513(a)(1) of the FD&C Act. temporary catheter for embolic
initial classification of the device. We classify devices into class II if protection during transcatheter
We believe this De Novo classification general controls by themselves are intracardiac procedures, and it is
will enhance patients’ access to insufficient to provide reasonable identified as a single use percutaneous
beneficial innovation, in part by assurance of safety and effectiveness, catheter system that has (a) blood
reducing regulatory burdens. When FDA but there is sufficient information to filter(s) at the distal end. This device is
classifies a device into class I or II via establish special controls that, in indicated for use while performing
the De Novo process, the device can combination with the general controls, transcatheter intracardiac procedures.
serve as a predicate for future devices of provide reasonable assurance of the The device is used to filter blood in a
that type, including for 510(k)s (see 21 safety and effectiveness of the device for manner that may prevent embolic
U.S.C. 360c(f)(2)(B)(i)). As a result, other its intended use (see 21 U.S.C. material (thrombus/debris) from the
device sponsors do not have to submit 360c(a)(1)(B)). After review of the transcatheter intracardiac procedure
a De Novo request or premarket information submitted in the request, from traveling towards the cerebral
approval application in order to market we determined that the device can be circulation.
a substantially equivalent device (see 21 classified into class II with the FDA has identified the following risks
U.S.C. 360c(i), defining ‘‘substantial establishment of special controls. FDA to health associated specifically with
equivalence’’). Instead, sponsors can use has determined that these special this type of device and the measures
the less-burdensome 510(k) process, controls, in addition to the general required to mitigate these risks in table
when necessary, to market their device. controls, will provide reasonable 1.

TABLE 1—TEMPORARY CATHETER FOR EMBOLIC PROTECTION DURING TRANSCATHETER INTRACARDIAC PROCEDURES
RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures

Device failure leading to debris embolization and stroke or death .......... Non-clinical performance testing, Animal testing, and Clinical perform-
ance testing.
Impeded or disrupted blood flow leading to peripheral ischemia ............ Non-clinical performance testing, Animal testing, Clinical performance
testing, and Labeling.
Device incompatibility with transcatheter intracardiac procedure device Non-clinical performance testing, Animal testing, Clinical performance
leading to prolonged treatment time or device failure. testing, and Labeling.
Adverse tissue reaction ............................................................................ Biocompatibility evaluation.
Infection .................................................................................................... Sterilization validation, Shelf life testing, and Labeling.
Vascular injury due to device delivery, deployment, placement, or re- Non-clinical performance testing, Animal testing, Clinical performance
trieval. testing, and Labeling.

FDA has determined that special IV. Paperwork Reduction Act of 1995 0910–0120; and the collections of
controls, in combination with the information in 21 CFR part 801,
general controls, address these risks to This final order establishes special regarding labeling, have been approved
health and provide reasonable assurance controls that refer to previously under OMB control number 0910–0485.
of safety and effectiveness. For a device approved collections of information
to fall within this classification, and found in other FDA regulations. These List of Subjects in 21 CFR Part 870
thus avoid automatic classification in collections of information are subject to
review by the Office of Management and Medical devices.
class III, it would have to comply with
the special controls named in this final Budget (OMB) under the Paperwork Therefore, under the Federal Food,
order. The necessary special controls Reduction Act of 1995 (44 U.S.C. 3501– Drug, and Cosmetic Act and under
appear in the regulation codified by this 3520). The collections of information in authority delegated to the Commissioner
order. This device is subject to the guidance document ‘‘De Novo of Food and Drugs, 21 CFR part 870 is
premarket notification requirements Classification Process (Evaluation of amended as follows:
under section 510(k) of the FD&C Act. Automatic Class III Designation)’’ have
been approved under OMB control PART 870—CARDIOVASCULAR
III. Analysis of Environmental Impact number 0910–0844; the collections of DEVICES
The Agency has determined under 21 information in part 814, subparts A
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CFR 25.34(b) that this action is of a type through E, regarding premarket ■ 1. The authority citation for part 870
that does not individually or approval, have been approved under continues to read as follows:
cumulatively have a significant effect on OMB control number 0910–0231; the
Authority: 21 U.S.C. 351, 360, 360c, 360e,
the human environment. Therefore, collections of information in part 807,
360j, 360l, 371.
neither an environmental assessment subpart E, regarding premarket
nor an environmental impact statement notification submissions, have been ■ 2. Add § 870.1251 to subpart B to read
is required. approved under OMB control number as follows:

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Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations 4141

§ 870.1251 Temporary catheter for embolic (4) Performance data must and effectiveness of the device. We
protection during transcatheter intracardiac demonstrate the sterility of the device believe this action will also enhance
procedures. components intended to be provided patients’ access to beneficial innovative
(a) Identification. This device is a sterile. devices, in part by reducing regulatory
single use percutaneous catheter system (5) Performance data must support the burdens.
that has (a) blood filter(s) at the distal shelf life of the device by demonstrating DATES: This order is effective January
end. This device is indicated for use continued sterility, package integrity, 30, 2018. The classification was
while performing transcatheter and device functionality over the applicable on December 20, 2016.
intracardiac procedures. The device is identified shelf life. FOR FURTHER INFORMATION CONTACT:
used to filter blood in a manner that (6) Labeling for the device must
may prevent embolic material Steven Elliott, Center for Devices and
include: Radiological Health, Food and Drug
(thrombus/debris) from the transcatheter (i) Instructions for use;
intracardiac procedure from traveling Administration, 10903 New Hampshire
(ii) Compatible transcatheter Ave., Bldg. 66, Rm. 2565, Silver Spring,
towards the cerebral circulation. intracardiac procedure devices;
(b) Classification. Class II (special MD 20993–0002, 301–796–5285,
(iii) A detailed summary of the steven.elliott@fda.hhs.gov.
controls). The special controls for this clinical testing conducted; and
device are: SUPPLEMENTARY INFORMATION:
(iv) A shelf life and storage
(1) Non-clinical performance testing I. Background
conditions.
must demonstrate that the device
(7) Clinical performance testing must Upon request, FDA has classified the
performs as intended under anticipated
demonstrate: surgical smoke precipitator as class II
conditions of use. The following
(i) The ability to safely deliver, (special controls), which we have
performance characteristics must be
deploy, and remove the device; determined will provide a reasonable
tested:
(i) Simulated-use testing in a (ii) The ability of the device to filter assurance of safety and effectiveness. In
clinically relevant bench anatomic embolic material while not impeding addition, we believe this action will
model to assess the following: blood flow; enhance patients’ access to beneficial
(A) Delivery, deployment, and (iii) Secure positioning and stability innovation, in part by reducing
retrieval, including quantifying of the position throughout the regulatory burdens by placing the
deployment and retrieval forces, and transcatheter intracardiac procedure; device into a lower device class than the
procedural time; and and automatic class III assignment.
(B) Device compatibility and lack of (iv) Evaluation of all adverse events The automatic assignment of class III
interference with the transcatheter including death, stroke, and vascular occurs by operation of law and without
intracardiac procedure and device. injury. any action by FDA, regardless of the
(ii) Tensile strengths of joints and Dated: January 24, 2018. level of risk posed by the new device.
components, tip flexibility, torque Leslie Kux, Any device that was not in commercial
strength, torque response, and kink Associate Commissioner for Policy. distribution before May 28, 1976, is
resistance. [FR Doc. 2018–01638 Filed 1–29–18; 8:45 am] automatically classified as, and remains
(iii) Flow characteristics. within, class III and requires premarket
(A) The ability of the filter to not BILLING CODE 4164–01–P
approval unless and until FDA takes an
impede blood flow. action to classify or reclassify the device
(B) The amount of time the filter can (see 21 U.S.C. 360c(f)(1)). We refer to
be deployed in position and/or retrieved DEPARTMENT OF HEALTH AND
HUMAN SERVICES these devices as ‘‘postamendments
from its location without disrupting devices’’ because they were not in
blood flow. Food and Drug Administration commercial distribution prior to the
(iv) Characterization and verification date of enactment of the Medical Device
of all dimensions. Amendments of 1976, which amended
(2) Animal testing must demonstrate 21 CFR Part 878
the Federal Food, Drug, and Cosmetic
that the device performs as intended [Docket No. FDA–2017–N–6598]
Act (FD&C Act).
under anticipated conditions of use. The
Medical Devices; General and Plastic FDA may take a variety of actions in
following performance characteristics
Surgery Devices; Classification of the appropriate circumstances to classify or
must be assessed:
(i) Delivery, deployment, and Surgical Smoke Precipitator reclassify a device into class I or II. We
retrieval, including quantifying may issue an order finding a new device
procedural time. AGENCY: Food and Drug Administration, to be substantially equivalent under
(ii) Device compatibility and lack of HHS. section 513(i) of the FD&C Act (21
interference with the transcatheter ACTION: Final order. U.S.C. 360c(i)) to a predicate device that
intracardiac procedure and device. does not require premarket approval.
(iii) Flow characteristics. SUMMARY: The Food and Drug We determine whether a new device is
(A) The ability of the filter to not Administration (FDA or we) is substantially equivalent to a predicate
impede blood flow. classifying the surgical smoke by means of the procedures for
(B) The amount of time the filter can precipitator into class II (special premarket notification under section
be deployed in position and/or retrieved controls). The special controls that 510(k) of the FD&C Act and part 807 (21
from its location without disrupting apply to the device type are identified U.S.C. 360(k) and 21 CFR part 807,
rmajette on DSKBCKNHB2PROD with RULES

blood flow. in this order and will be part of the respectively).
(iv) Gross pathology and codified language for the surgical smoke FDA may also classify a device
histopathology assessing vascular injury precipitator’s classification. We are through ‘‘De Novo’’ classification, a
and downstream embolization. taking this action because we have common name for the process
(3) All patient contacting components determined that classifying the device authorized under section 513(f)(2) of the
of the device must be demonstrated to into class II (special controls) will FD&C Act. Section 207 of the Food and
be biocompatible. provide a reasonable assurance of safety Drug Administration Modernization Act

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Document Created: 2018-10-26 10:11:55
Document Modified: 2018-10-26 10:11:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective January 30, 2018. The classification was applicable on June 1, 2017.
Contact		Sadaf Toor, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1202, Silver Spring, MD 20993-0002, 301-796-6381, [email protected]
FR Citation		83 FR 4139

83 FR 4139 - Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration