CAPIOX CARDIOTOMY RESERVOIR

CAPIOX CARDIOTOMY RESERVOIR is an FDA 510(k)-cleared medical device (K033800) manufactured by Terumo Cardiovascular Systems Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2004. Regulation: 8.