510(k) K913143

OCHSNER ULP BIFURCATION VASCULAR PROTHESIS by Intervascular, Inc. — Product Code DSY

K913143 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "OCHSNER ULP BIFURCATION VASCULAR PROTHESIS". The FDA issued a decision of Substantially Equivalent on Oct 23, 1991. 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.