CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR870.1255]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 870 -- CARDIOVASCULAR DEVICES

Subpart B - Cardiovascular Diagnostic Devices

Sec. 870.1255 Balloon aortic valvuloplasty catheter.

(a) Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device must be demonstrated to be biocompatible.

(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.

(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.

(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.

(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.

[82 FR 34852, July 27, 2017]