510(k) K950751

TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES by Medtronic Vascular — Product Code DXY

K950751 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES". The FDA issued a decision of ST on May 15, 1995. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Medtronic Vascular has at least 10 other 510(k) clearances on record.