VASCUTEK GELSOFT PLUS VASCULAR GRAFT

VASCUTEK GELSOFT PLUS VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K955230) 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 February 8, 1996. Regulation: 8.