ARTERIAL BLOOD FILTER MODEL #AF-1040

ARTERIAL BLOOD FILTER MODEL #AF-1040 is an FDA 510(k)-cleared medical device (K820343) 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 June 16, 1982. Regulation: 8.