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FDA 510(k), K214114, Prodigy Thrombectomy System
FDA 510(k), K214114, Prodigy Thrombectomy System
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$149.00 USD
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510(K) Number: K214114
Device Name: Prodigy Thrombectomy System
Manufacturer: Micheal Buck
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: 12/30/2021
Date Received: 04/06/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Prodigy Thrombectomy System
Manufacturer: Micheal Buck
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: 12/30/2021
Date Received: 04/06/2022
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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