510(k) K950425

TECOTHANE 55D by Medtronic Vascular — Product Code GZF

K950425 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "TECOTHANE 55D". The FDA issued a decision of Substantially Equivalent on April 19, 1995. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Medtronic Vascular has at least 10 other 510(k) clearances on record.