Panels › Cardiovascular › Product code DXY · Class 3

Implantable Pacemaker Pulse-Generator

Regulation 870.3610

0510(k)s in 12 months (461 all time)

0recalls in 12 months (75 all time)

1recalls that name a 510(k)

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Top companies in DXY

Company	510(k)s	Recalls
Medtronic Vascular	59	0
Intermedics, Inc.	52	0
Telectronics, Inc.	47	0
Cardiac Pacemakers, Inc.	37	0
Guidant Corp-Cpi Division	0	32
Pacesetter Systems	28	0
Cook Pacemaker Corp.	24	0
Ela Medical, Inc.	22	2
Biotronik Sales, Inc.	22	0
Cordis Corp.	21	0

Date	Firm and product	Code	Linked 510(k)
May 29, 2003	Guidant Corp-Cpi Division Contak TR Multiprogrammable Pacemaker, DDDR Model 1241 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1298 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1296 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1294 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Plus Multiprogrammable Pacemaker, DDD Model 986 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Insignia Plus Multiprogrammable Pacemaker, DDD Model 985 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Meridian Multiprogrammable Pacemaker, DDDR Model 1276 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Meridian Multiprogrammable Pacemaker, DDDR Model 1275 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, DDDR Model 1283 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, DDDR Model 1280 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, DDD Model 981 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Discovery Multiprogrammable Pacemaker, DDDR Model 1274 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Discovery Multiprogrammable Pacemaker, DDDR Model 1273 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1286 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Max II Multiprogrammable Pacemaker, DDDR Model 1284 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Max Multiprogrammable Pacemaker Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Multiprogrammable Pacemaker, DDDR Model 1272 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Multiprogrammable Pacemaker, DDDR Model 1270 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Multiprogrammable Pacemaker, DDD Model 976 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Multiprogrammable Pacemaker, DDD Model 972 Terminated	DXY	None listed
May 29, 2003	Guidant Corp-Cpi Division Pulsar Multiprogrammable Pacemaker, DDD Model 970 Terminated	DXY	None listed
Feb 26, 2003	Cook Biotech, Inc. Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. Terminated	DXY	K001785
Dec 18, 2002	St Jude Medical Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-03 Terminated	DXY	None listed

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