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FDA 510(k), K202251, Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
FDA 510(k), K202251, Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
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510(K) Number: K202251
Device Name: Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 08/10/2020
Decision Date: 08/31/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 08/10/2020
Decision Date: 08/31/2020
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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