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FDA 510(k), K202345, FlowTriever Retrieval/Aspiration System
FDA 510(k), K202345, FlowTriever Retrieval/Aspiration System
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510(K) Number: K202345
Device Name: FlowTriever Retrieval/Aspiration System
Manufacturer: Eben Gordon
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: 08/18/2020
Date Received: 12/18/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: FlowTriever Retrieval/Aspiration System
Manufacturer: Eben Gordon
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: 08/18/2020
Date Received: 12/18/2020
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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