510(k) K854919

BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY by Cook Pacemaker Corp. — Product Code DXY

K854919 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY". The FDA issued a decision of Substantially Equivalent on December 19, 1985. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.