510(k) K861422

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY by Pacesetter Systems — Product Code DXY

K861422 is an FDA 510(k) premarket notification submitted by Pacesetter Systems for the device "PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY". The FDA issued a decision of Substantially Equivalent on June 26, 1986. 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.