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GUIDANCE DOCUMENT

Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019

Final
Docket Number:
FDA-2018-D-1775
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.  The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. For the purposes of this guidance, the coronary vasculature includes blood vessels within the heart, including the ostium of the left main coronary artery; the neurovasculature includes blood vessels within the cranium, typically considered the vasculature distal to the cervical segment of the internal carotid artery; the peripheral vasculature includes all other cardiovascular vasculature. This document is intended to assist industry in designing and executing appropriate performance testing to support a 510(k) submission and provides recommendations for content and labeling to include in the submission.


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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-1775.