Penumbra System (RED 68 Reperfusion Catheter)

Penumbra System (RED 68 Reperfusion Catheter) is an FDA 510(k)-cleared medical device (K211411) 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 June 30, 2021. Regulation: 8.