PTFE RINGED GORE-TEX VASCULAR GRAFT

PTFE RINGED GORE-TEX VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K991683) 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 September 7, 1999. Regulation: 8.