EVOLVE Nitric Oxide Delivery System

EVOLVE Nitric Oxide Delivery System is an FDA 510(k)-cleared medical device (K242578) manufactured by Mallinckrodt Manufacturing, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2025. Regulation: 8.