510(k) K000105

MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), by Medtronic Vascular — Product Code GZF

K000105 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),". The FDA issued a decision of Substantially Equivalent on April 12, 2000. 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.