CAPIOX CARDIOTOMY RESERVOIR

CAPIOX CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K030505) manufactured by Terumo Cardiovascular Systems 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 May 13, 2003. Regulation: 8.