510(k) K964625

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES by Intervascular, Inc. — Product Code DSY

K964625 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES". The FDA issued a decision of ST on May 5, 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. Intervascular, Inc. has at least 10 other 510(k) clearances on record.