GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE is an FDA 510(k)-cleared medical device (K122301) manufactured by Vascular Solutions Zerusa , Ltd.. 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 6, 2012. Regulation: 8.