Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 is an FDA 510(k)-cleared medical device (K193595) 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 August 18, 2020. Regulation: 8.