INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)

INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) is an FDA 510(k)-cleared medical device (K220683) 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 October 3, 2022. Regulation: 8.