510(k) K925106

IMPLANTABLE PULSE GENERATORS by Medtronic Vascular — Product Code DYX

K925106 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "IMPLANTABLE PULSE GENERATORS". The FDA issued a decision of Substantially Equivalent on October 6, 1993. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. Medtronic Vascular has at least 10 other 510(k) clearances on record.