510(k) K853400

CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK by Cardiac Control Systems, Inc. — Product Code DXY

K853400 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK". The FDA issued a decision of Substantially Equivalent on February 24, 1986. 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.