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FDA 510(k), K190010, Penumbra System Reperfusion Catheter JET 7
FDA 510(k), K190010, Penumbra System Reperfusion Catheter JET 7
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510(K) Number: K190010
Device Name: Penumbra System Reperfusion Catheter JET 7
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 01/03/2019
Decision Date: 06/16/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Penumbra System Reperfusion Catheter JET 7
Manufacturer: Penumbra, Inc.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 01/03/2019
Decision Date: 06/16/2019
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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