U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff February 2020

Final
Docket Number:
FDA-2018-D-2494
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Dockets Management
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.

Back to Top