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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All written comments should be identified with this document's docket number: FDA-2018-D-2494.