510(k) K960631

MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX by Medtronic Vascular — Product Code GZF

K960631 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX". The FDA issued a decision of Substantially Equivalent on May 21, 1996. 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.