AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE

AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE is an FDA 510(k)-cleared medical device (K033468) 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 November 13, 2003. Regulation: 8.