GORE-TEX CARDIOVASCULAR PATCH

GORE-TEX CARDIOVASCULAR PATCH is an FDA 510(k)-cleared medical device (K940906) 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 May 17, 1994. Regulation: 8.