
W. L. Gore & Associates, Inc.
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GORE ACUSEAL VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K130215) 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 April 8, 2013. Regulation: 8.