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

Issue Date: May 20, 2021
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Cardiovascular , Labeling
Status: Final

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

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.

Download the Guidance Document