Affinity Fusion™ Oxygenator System

Affinity Fusion™ Oxygenator System is an FDA 510(k)-cleared medical device (K230640) 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 April 5, 2023. Regulation: 8.