FDA 510(k), K201705, ReVene Thrombectomy Catheter

FDA 510(k), K201705, ReVene Thrombectomy Catheter

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510(K) Number: K201705
Device Name: ReVene Thrombectomy Catheter
Manufacturer: Mark Bruzzi
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 06/22/2020
Decision Date: 12/22/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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