AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354

AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 is an FDA 510(k)-cleared medical device (K994208) manufactured by Medtronic Perfusion Systems. 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 12, 2000. Regulation: 8.