MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR

MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K070839) 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 April 23, 2007. Regulation: 8.