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GUIDANCE DOCUMENT

Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and Food and Drug Administration Staff May 2021

Download the Final Guidance Document Read the Federal Register Notice
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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2018-D-2494.

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