INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE is an FDA 510(k)-cleared medical device (K900998) manufactured by Intec Medical, 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 August 13, 1990. Regulation: 8.