510(k) K964665

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) by Carbomedics, Inc. — Product Code DSY

K964665 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)". The FDA issued a decision of ST on February 19, 1997. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.