Penumbra System (Reperfusion Catheter RED 43)

Penumbra System (Reperfusion Catheter RED 43) is an FDA 510(k)-cleared medical device (K222808) manufactured by Penumbra, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2022. Regulation: 8.