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# Guide on Peripheral Vascular Atherectomy Devices
- URL: https://www.fdaweb.com/guide-on-peripheral-vascular-atherectomy-devices/
- Published: 2018-07-26T12:00:00.000Z
- Updated: 2026-09-15T00:21:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141971

FDA has released a [draft guidance ](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM614752.pdf?ref=fdaweb.com)entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification \[510(k)\] Submissions.” The document says that atherectomy devices vary in design and complexity and there are currently four main categories. The choice of an atherectomy device depends on plaque location, vessel characteristics, length of disease segment, plaque quantity, plaque texture, and physician experience, it notes. The guidance encourages industry to engage CDRH under its Pre-Submission process to obtain feedback based on device indications and operational characteristics.