VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) is an FDA 510(k)-cleared medical device (K964665) 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 February 18, 1997. Regulation: 8.