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# Peripheral Vascular Atherectomy Device Guidance
- URL: https://www.fdaweb.com/peripheral-vascular-atherectomy-device-guidance/
- Published: 2020-02-12T12:00:00.000Z
- Updated: 2026-09-14T16:02:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146073

FDA has published a guidance, *Peripheral Vascular Atherectomy Devices—Premarket Notification 510(k) Submissions*, with recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The [document](https://www.fda.gov/media/114852/download?ref=fdaweb.com) says its recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular submissions.

Included in the guidance are Introduction, Background, Scope, Premarket Submission Recommendations (device description, predicate device comparison, software, biocompatibility, sterility, pyrogenicity, shelf life and packaging, electrical safety and electromagnetic compatibility, battery testing, non-clinical performance testing, animal testing, clinical performance testing, labeling), and Modifications.