INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER

INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER is an FDA 510(k)-cleared medical device (K874841) manufactured by Bentley Laboratories, Inc.. 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 1, 1988. Regulation: 8.