Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System is an FDA 510(k)-cleared medical device (K203111) manufactured by Medtronic. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 2021. Regulation: 8.