510(k) K860585

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR by Cardiac Pacemakers, Inc. — Product Code DXY

K860585 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on July 16, 1986. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.