CARDIOTOMY RESERVOIR WITH FILTER

CARDIOTOMY RESERVOIR WITH FILTER is an FDA 510(k)-cleared medical device (K801360) manufactured by Travenol Laboratories, S.A.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1980. Regulation: 8.