510(k) K885267

VS-1 MODEL NUMBER 251K PULSE GENERATOR by Pacesetter Systems — Product Code DXY

K885267 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "VS-1 MODEL NUMBER 251K PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on March 28, 1989. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Pacesetter Systems has at least 10 other 510(k) clearances on record.