ARTERIAL BLOOD FILTER AF-1025-AF-1025BL

ARTERIAL BLOOD FILTER AF-1025-AF-1025BL is an FDA 510(k)-cleared medical device (K830131) 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 January 27, 1983. Regulation: 8.