510(k) K884023

MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER by Cardiac Control Systems, Inc. — Product Code DXY

K884023 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER". The FDA issued a decision of Substantially Equivalent on October 17, 1988. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.