VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K960706) manufactured by Carbomedics, 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 24, 1996. Regulation: 8.