510(k) K946188

CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER by Cardiac Control Systems, Inc. — Product Code DXY

K946188 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER". The FDA issued a decision of ST on May 15, 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.