510(k) K983819

INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN by Intervascular, Inc. — Product Code DSY

K983819 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN". The FDA issued a decision of Substantially Equivalent on Nov 24, 1998. 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.