TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES

TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES is an FDA 510(k)-cleared medical device (K901247) 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 July 30, 1990. Regulation: 8.