CAPIOX CR-CARDIOTOMY RESERVOIR

CAPIOX CR-CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K821538) manufactured by Terumo Medical Corp.. 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 5, 1982. Regulation: 8.