VASCUTEK TWILLWEAVE VASCULAR GRAFT

VASCUTEK TWILLWEAVE VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K964959) 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 March 9, 1997. Regulation: 8.