Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister

Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister is an FDA 510(k)-cleared medical device (K180412) 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 May 14, 2018. Regulation: 8.