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)
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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 1977 | K770328 | PACEMAKER, ANTRIO-VENTRICULAR SEQ. American Pacemaker Corp. | DXY |
| Feb 24, 1977 | K770005 | PACEMAKER 208S Elema-Schonander, Inc. | DXY |
| Feb 7, 1977 | K770198 | BIPOLAR ASYNCHRONOUS PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Feb 7, 1977 | K770197 | UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Feb 7, 1977 | K770135 | LEAD MODIFICATION Elema-Schonander, Inc. | DXY |
| Dec 23, 1976 | K761143 | LITHIUM IODIDE BATTERY PACEMAKER (#201) Pacesetter Systems | DXY |
| Dec 21, 1976 | K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 Arco Medical Products Co. | DXY |
| Nov 12, 1976 | K760671 | PACEMAKERS, VITATRONS (SERIES 3000) Vitatron Medical BV | DXY |
| Nov 12, 1976 | K760670 | PACEMAKERS, VITATRONS (SERIES 2000) Vitatron Medical BV | DXY |
| Nov 12, 1976 | K760669 | PACEMAKERS, VITATRON'S Vitatron Medical BV | DXY |
| Nov 11, 1976 | K760757 | MODEL 100 CARDIAC PACEMAKER Pacesetter Systems | DXY |
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