Penumbra System ACE 68 Reperfusion Catheter

Penumbra System ACE 68 Reperfusion Catheter is an FDA 510(k)-cleared medical device (K161064) 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 11, 2016. Regulation: 8.