ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K013577) manufactured by Atrium Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 2002. Regulation: 8.