ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012

ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 is an FDA 510(k)-cleared medical device (K910845) manufactured by Interventional Therapeutics Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 1991. Regulation: 8.