510(k) K874158

CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. by Cardiac Control Systems, Inc. — Product Code DXY

K874158 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.". The FDA issued a decision of Substantially Equivalent on December 29, 1987. 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.