510(k) K860202

MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. by Cook Pacemaker Corp. — Product Code DXY

K860202 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.". The FDA issued a decision of Substantially Equivalent on February 24, 1986. 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.