VENOUS RESERVOIR W/CARDIOTOMY FILTER

VENOUS RESERVOIR W/CARDIOTOMY FILTER is an FDA 510(k)-cleared medical device (K915573) manufactured by Baxter Healthcare 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 December 22, 1992. Regulation: 8.