Nautilus VF ECMO Oxygenator

Nautilus VF ECMO Oxygenator is an FDA 510(k)-cleared medical device (K232767) manufactured by Mc3, 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 October 3, 2023. Regulation: 8.