510(k) K871861

IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS by Telectronics, Inc. — Product Code DXY

K871861 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Telectronics, Inc. has at least 10 other 510(k) clearances on record.