510(k) K800326

ARCOLITH 3021-CARDIAC PULSE GENERATOR by Arco Medical Products Co. — Product Code DXY

K800326 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "ARCOLITH 3021-CARDIAC PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on March 17, 1980. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.