> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Peripheral Atherectomy Device Updated Guidance
- URL: https://www.fdaweb.com/peripheral-atherectomy-device-updated-guidance/
- Published: 2021-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:59:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149351

FDA has published an updated final guidance, *Peripheral Vascular Atherectomy Devices—Premarket Notification \[510(k)\] Submissions*, with recommendations for 510(k) submissions for these devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/peripheral-vascular-atherectomy-devices-premarket-notification-510k-submissions?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions.

In an online [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/2d99cf4?ref=fdaweb.com), CDRH says the final guidance was initially issued on 2/13/20\. It says the updates align with current review practices of similar cardiovascular devices and cover clarification of pyrogenicity language, an addition to the simulated-use testing recommendations, and addition of a particulate evaluation section.