GORE-TEX(R) STRETCH VASCULAR GRAFT

GORE-TEX(R) STRETCH VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K903931) 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 December 5, 1990. Regulation: 8.