GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE is an FDA 510(k)-cleared medical device (K082356) manufactured by W. L. Gore & Associates, 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 27, 2008. Regulation: 8.