FDA 510(k), K142458, Penumbra System ACE
FDA 510(k), K142458, Penumbra System ACE
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$149.00 USD
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510(K) Number: K142458
Device Name: Penumbra System ACE
Manufacturer: PENUMBRA, INC.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 09/02/2014
Decision Date: 05/22/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Penumbra System ACE
Manufacturer: PENUMBRA, INC.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 09/02/2014
Decision Date: 05/22/2015
Regulation Medical Specialty: Cardiovascular