Penumbra System ACE 64 and ACE 68 Reperfusion Catheters

Penumbra System ACE 64 and ACE 68 Reperfusion Catheters is an FDA 510(k)-cleared medical device (K152541) 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 January 12, 2016. Regulation: 8.