Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, February 13, 2020
Language(s):
English
Format:
Text
Subject(s):
Atherectomy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (27 pages)).
NLM Unique ID:
101772601 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772601