FDA 510(k) K222808, Penumbra System (Reperfusion Catheter RED 43), by Penumbra, Inc.
FDA 510(k) K222808, Penumbra System (Reperfusion Catheter RED 43), by Penumbra, Inc.
Device Classification Name: Catheter, Thrombus Retriever
510(k) Number: K222808
Device Name: Penumbra System (Reperfusion Catheter RED 43)
Applicant: Penumbra, Inc.
Regulation Number: 870.125
Classification Product Code: NRY
Date Received: 2022-09-16
Decision Date: 2022-12-20
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Neurology
Total number of pages: 1,917
Fully redacted pages: 1,787
Content pages: 130
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