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FDA 510(k) K161640, Penumbra System ACE 68 Reperfusion Catheter, by Penumbra, Inc.

FDA 510(k) K161640, Penumbra System ACE 68 Reperfusion Catheter, by Penumbra, Inc.

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510(K) Number: K161640
Device Name: Penumbra System ACE 68 Reperfusion Catheter
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 06/14/2016
Decision Date: 07/12/2016
Regulation Medical Specialty: Cardiovascular
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