GORE® ACUSEAL Vascular Graft

GORE® ACUSEAL Vascular Graft is an FDA 510(k)-cleared medical device (K231505) 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 June 22, 2023. Regulation: 8.