Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface is an FDA 510(k)-cleared medical device (K162896) manufactured by Medtronic, 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 December 5, 2016. Regulation: 8.