510(k) K984294

MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES by Intervascular, Inc. — Product Code DSY

K984294 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES". The FDA issued a decision of Substantially Equivalent on Feb 22, 1999. 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, Inc. has at least 10 other 510(k) clearances on record.