Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
Information
Type
Rule
Regulated products
Medical Devices
Published
July 27, 2017
Last updated
July 27, 2017
Description
Document number 2017-15786. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)