FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS

FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS is an FDA 510(k)-cleared medical device (K933943) 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 7, 1993. Regulation: 8.