510(k) K940039

PELLETHANE 75D by Medtronic Vascular — Product Code DXY

K940039 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "PELLETHANE 75D". The FDA issued a decision of ST on July 12, 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.