GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE is an FDA 510(k)-cleared medical device (K914447) 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 November 4, 1991. Regulation: 8.