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FDA 510(k), K210911, WOLF Thrombectomy System, 14F
FDA 510(k), K210911, WOLF Thrombectomy System, 14F
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$149.00 USD
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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: 03/29/2021
Date Received: 10/19/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: WOLF Thrombectomy System, 14F
Manufacturer: Michael P Wallace
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: 03/29/2021
Date Received: 10/19/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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