AOR-TEX VASCULAR GRAFT

AOR-TEX VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K933987) 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 May 16, 1994. Regulation: 8.