510(k) K854845

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR by Intervascular, Inc. — Product Code DSY

K854845 is an FDA 510(k) premarket notification submitted by Intervascular, Inc. for the device "INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR". The FDA issued a decision of Substantially Equivalent on Aug 18, 1986. 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.