FDA 510(k), K210911, WOLF Thrombectomy System, 14F

FDA 510(k), K210911, WOLF Thrombectomy System, 14F

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510(K) Number: K210911
Device Name: WOLF Thrombectomy System, 14F
Manufacturer: Michael P Wallace
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 03/29/2021
Decision Date: 10/19/2021
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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