Thrombuster II Aspiration Catheter

Thrombuster II Aspiration Catheter is an FDA 510(k)-cleared medical device (K213166) manufactured by Kaneka Medical America, LLC. 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 25, 2021. Regulation: 8.