Affinity NT Oxygenator with Cortiva BioActive Surface

Affinity NT Oxygenator with Cortiva BioActive Surface is an FDA 510(k)-cleared medical device (K162016) 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 September 20, 2016. Regulation: 8.