OXYGENATOR MODEL NO. BENTLEY-10 PLUS

OXYGENATOR MODEL NO. BENTLEY-10 PLUS is an FDA 510(k)-cleared medical device (K863249) manufactured by American Bentley. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 1986. Regulation: 8.