510(k) K960706

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT by Carbomedics, Inc. — Product Code DSY

K960706 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT". The FDA issued a decision of SESP on April 25, 1996. 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.