510(k) K880422

MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER by Cardiac Control Systems, Inc. — Product Code DXY

K880422 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER". The FDA issued a decision of Substantially Equivalent on March 31, 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.