GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT

GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K013250) 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 25, 2001. Regulation: 8.