Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Labeling, Premarket
Published
May 20, 2021
Last updated
May 19, 2021
Description
This document provides guidance for industry and FDA staff on premarket notification submissions for peripheral vascular atherectomy devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)