TANDEMHEART FEMORAL VENOUS CANNULA SET

TANDEMHEART FEMORAL VENOUS CANNULA SET is an FDA 510(k)-cleared medical device (K133236) manufactured by Cardiacassist, 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 28, 2014. Regulation: 8.