510(k) K801806

EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE by Arco Medical Products Co. — Product Code DXY

K801806 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE". The FDA issued a decision of Substantially Equivalent on September 9, 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.