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 |
|---|---|---|---|
| Sep 18, 1980 | K800793 | IMPLANTABLE PROGRAM. CARDIAC PACEMAKER Telectronics, Inc. | DXY |
| Sep 16, 1980 | K801508 | SIEMENS-ELEMA PULSE GENERATOR 625 Siemens Elema AB | DXY |
| Sep 9, 1980 | K802040 | BATTERY FOR #229-01 PULSE GENERATOR Intermedics, Inc. | DXY |
| Sep 9, 1980 | K801910 | INSULATING SHEATH Cordis Corp. | DXY |
| Sep 9, 1980 | K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE Arco Medical Products Co. | DXY |
| Sep 9, 1980 | K800226 | MEDTRONIC MODEL 2409 Medtronic Vascular | DXY |
| Aug 27, 1980 | K801763 | VIVALITH 5, - MDL-201A & TDL-201A Pacesetter Systems | DXY |
| Aug 20, 1980 | K801647 | SONACOLOR 6100 Carolina Medical Electronics | DXY |
| Aug 14, 1980 | K801450 | INTERMEDICS THIN LITH IV SERIES UNIPOLAR Intermedics, Inc. | DXY |
| Jul 8, 1980 | K801106 | MULTICOR (GAMMA) MODEL 336 & MODEL 337 Cordis Corp. | DXY |
| Jun 30, 1980 | K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. Arco Medical Products Co. | DXY |
| Jun 30, 1980 | K801122 | MICROTHIN-D1 (MOD. 0620) Cardiac Pacemakers, Inc. | DXY |
| Jun 30, 1980 | K801121 | MICROTHIN-P1 (MOD. 0622) Cardiac Pacemakers, Inc. | DXY |
| Jun 30, 1980 | K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR Arco Medical Products Co. | DXY |
| Jun 26, 1980 | K800069 | MEDTRONIC MODELS 5966/5967, ETC. Medtronic Vascular | DXY |
| Jun 4, 1980 | K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. Arco Medical Products Co. | DXY |
| May 20, 1980 | K800285 | MODEL 5985 PACEMAKER PULSE GENERATOR Medtronic Vascular | DXY |
| May 2, 1980 | K800387 | PULSE GENERATORS MODELS 657 & 677 Siemens Elema AB | DXY |
| Apr 24, 1980 | K800895 | MODEL 253-11 CYBERLITH PULSE GENERATOR Intermedics, Inc. | DXY |
| Apr 16, 1980 | K800644 | CYBERLITH IMPLANTABLE PULSE GEN. #253-02 Intermedics, Inc. | DXY |
| Apr 16, 1980 | K800375 | NOMOS-01 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 8, 1980 | K800645 | CYBERLITH IMPLANTABLE PULSE GEN. #253-04 Intermedics, Inc. | DXY |
| Mar 25, 1980 | K800573 | IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC Telectronics, Inc. | DXY |
| Mar 17, 1980 | K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR Arco Medical Products Co. | DXY |
| Feb 11, 1980 | K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER Coratomic, Inc. | DXY |
| Feb 5, 1980 | K792565 | SORIN PULSE GENERATOR MODEL # LIT 214 H Bentley Laboratories, Inc. | DXY |
| Feb 5, 1980 | K792526 | PULSE GENERATOR, MODEL NO. LIT 222 Bentley Laboratories, Inc. | DXY |
| Jan 31, 1980 | K800027 | MICROTHIN-PI Cardiac Pacemakers, Inc. | DXY |
| Jan 31, 1980 | K800026 | MICROTHIN-DI Cardiac Pacemakers, Inc. | DXY |
| Jan 11, 1980 | K800030 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. Telectronics, Inc. | DXY |
| Dec 20, 1979 | K792519 | IMPLANTABLE PROGRAMMABLE UNIPOLAR Telectronics, Inc. | DXY |
| Nov 29, 1979 | K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR Arco Medical Products Co. | DXY |
| Nov 29, 1979 | K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR Arco Medical Products Co. | DXY |
| Nov 29, 1979 | K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 Vitatron Medical BV | DXY |
| Nov 27, 1979 | K792232 | UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR American Pacemaker Corp. | DXY |
| Nov 27, 1979 | K792199 | UNIFOCAL 2-UNIPOLAR & BIPOLAR American Pacemaker Corp. | DXY |
| Nov 27, 1979 | K791955 | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE American Pacemaker Corp. | DXY |
| Nov 15, 1979 | K791316 | MEDTRONIC MODELS 5984/5985 Medtronic Vascular | DXY |
| Oct 26, 1979 | K791921 | CARDIAC PACEMAKER C4000, C1000 SER. Vitatron Medical BV | DXY |
| Oct 22, 1979 | K792052 | IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD Telectronics, Inc. | DXY |
| Oct 22, 1979 | K791783 | OMNI-STANICOR (THETA) MOD 237A Cordis Corp. | DXY |
| Oct 12, 1979 | K790792 | PULSE GENERATOR MODEL 637 Elema-Schonander, Inc. | DXY |
| Sep 28, 1979 | K791784 | CORDIS BIPOLAR PACER CONNECTOR SYSTEM Cordis Corp. | DXY |
| Sep 28, 1979 | K790068 | PULSE GENERATORS, MODELS 5983, 5989 Medtronic Vascular | DXY |
| Sep 27, 1979 | K791727 | IMPLANTABLE VENTRICULAR-INHIBITED Telectronics, Inc. | DXY |
| Sep 27, 1979 | K791715 | ARCOLITH 2000 Arco Medical Products Co. | DXY |
| Sep 26, 1979 | K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR Edwards Pacemaker Systems | DXY |
| Sep 20, 1979 | K791181 | PROGRAMMER, MEDTRONIC MODEL 5984/5985 Medtronic Vascular | DXY |
| Sep 20, 1979 | K790873 | MODEL 221 PROGRAMALITH PULSE GENERATOR Pacesetter Systems | DXY |
| Sep 19, 1979 | K791568 | IMPLANTABLE PULSE GENERATOR PACEMAKERS Intermedics, Inc. | DXY |
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