510(k) K013651

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS by Intervascular — Product Code DSY

K013651 is an FDA 510(k) premarket notification submitted by Intervascular for the device "INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on Feb 27, 2002. 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. Intervascular has at least 10 other 510(k) clearances on record.