BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

BIFURCATED GORE TEX STRETCH VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K904282) 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 January 15, 1991. Regulation: 8.