510(k) K950210

CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER by Cardiac Control Systems, Inc. — Product Code DXY

K950210 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER". The FDA issued a decision of ST on May 3, 1995. 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.