VASCUTEK GELWEAVE VASCULAR GRAFT

VASCUTEK GELWEAVE VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K952293) manufactured by Vascutek, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 1995. Regulation: 8.