GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE

GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE is an FDA 510(k)-cleared medical device (K930950) 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 October 21, 1993. Regulation: 8.