Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
fda-device · Food and Drug Administration · Rule · Published 2017-07-27 · Effective 2017-07-27 · 82 FR 34850
Document
Document number
2017-15786
Federal Register citation
82 FR 34850
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-07-27
Effective date
2017-07-27
HHS docket
Docket No. FDA-2017-N-1916
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.