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FDA 510(k), K072718, PENUMBRA SYSTEM
FDA 510(k), K072718, PENUMBRA SYSTEM
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510(K) Number: K072718
Device Name: PENUMBRA SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 09/25/2007
Decision Date: 12/28/2007
Regulation Medical Specialty: Cardiovascular
Device Name: PENUMBRA SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 09/25/2007
Decision Date: 12/28/2007
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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