Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff May 2021
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-2494.