FDA Product Code
FDA Product Code DXY — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3610
510(k) Clearances — 461 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K800793 | IMPLANTABLE PROGRAM. CARDIAC PACEMAKER | Telectronics, Inc. | 1980-09-18 | Traditional | PDF ↗ |
| K801508 | SIEMENS-ELEMA PULSE GENERATOR 625 | Siemens Elema AB | 1980-09-16 | Traditional | PDF ↗ |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | Arco Medical Products Co. | 1980-09-09 | Traditional | PDF ↗ |
| K800226 | MEDTRONIC MODEL 2409 | Medtronic Vascular | 1980-09-09 | Traditional | PDF ↗ |
| K802040 | BATTERY FOR #229-01 PULSE GENERATOR | Intermedics, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K801910 | INSULATING SHEATH | Cordis Corp. | 1980-09-09 | Traditional | PDF ↗ |
| K801763 | VIVALITH 5, - MDL-201A & TDL-201A | Pacesetter Systems | 1980-08-27 | Traditional | PDF ↗ |
| K801647 | SONACOLOR 6100 | Carolina Medical Electronics | 1980-08-20 | Traditional | PDF ↗ |
| K801450 | INTERMEDICS THIN LITH IV SERIES UNIPOLAR | Intermedics, Inc. | 1980-08-14 | Traditional | PDF ↗ |
| K801106 | MULTICOR (GAMMA) MODEL 336 & MODEL 337 | Cordis Corp. | 1980-07-08 | Traditional | PDF ↗ |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | Arco Medical Products Co. | 1980-06-30 | Traditional | PDF ↗ |
| K801122 | MICROTHIN-D1 (MOD. 0620) | Cardiac Pacemakers, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | Arco Medical Products Co. | 1980-06-30 | Traditional | PDF ↗ |
| K801121 | MICROTHIN-P1 (MOD. 0622) | Cardiac Pacemakers, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800069 | MEDTRONIC MODELS 5966/5967, ETC. | Medtronic Vascular | 1980-06-26 | Traditional | PDF ↗ |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | Arco Medical Products Co. | 1980-06-04 | Traditional | PDF ↗ |
| K800285 | MODEL 5985 PACEMAKER PULSE GENERATOR | Medtronic Vascular | 1980-05-20 | Traditional | PDF ↗ |
| K800387 | PULSE GENERATORS MODELS 657 & 677 | Siemens Elema AB | 1980-05-02 | Traditional | PDF ↗ |
| K800895 | MODEL 253-11 CYBERLITH PULSE GENERATOR | Intermedics, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K800375 | NOMOS-01 PULSE GENERATOR | Biotronik Sales, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800644 | CYBERLITH IMPLANTABLE PULSE GEN. #253-02 | Intermedics, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800645 | CYBERLITH IMPLANTABLE PULSE GEN. #253-04 | Intermedics, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K800573 | IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC | Telectronics, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | Arco Medical Products Co. | 1980-03-17 | Traditional | PDF ↗ |
| K800194 | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | Coratomic, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K792526 | PULSE GENERATOR, MODEL NO. LIT 222 | Bentley Laboratories, Inc. | 1980-02-05 | Traditional | PDF ↗ |
| K792565 | SORIN PULSE GENERATOR MODEL # LIT 214 H | Bentley Laboratories, Inc. | 1980-02-05 | Traditional | PDF ↗ |
| K800027 | MICROTHIN-PI | Cardiac Pacemakers, Inc. | 1980-01-31 | Traditional | PDF ↗ |
| K800026 | MICROTHIN-DI | Cardiac Pacemakers, Inc. | 1980-01-31 | Traditional | PDF ↗ |
| K800030 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. | Telectronics, Inc. | 1980-01-11 | Traditional | PDF ↗ |
| K792519 | IMPLANTABLE PROGRAMMABLE UNIPOLAR | Telectronics, Inc. | 1979-12-20 | Traditional | PDF ↗ |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | Arco Medical Products Co. | 1979-11-29 | Traditional | PDF ↗ |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | Arco Medical Products Co. | 1979-11-29 | Traditional | PDF ↗ |
| K791920 | CARDIAC PACEMAKER P4000 SER. & P1000 | Vitatron Medical BV | 1979-11-29 | Traditional | PDF ↗ |
| K791955 | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE | American Pacemaker Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K792232 | UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR | American Pacemaker Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K792199 | UNIFOCAL 2-UNIPOLAR & BIPOLAR | American Pacemaker Corp. | 1979-11-27 | Traditional | PDF ↗ |
| K791316 | MEDTRONIC MODELS 5984/5985 | Medtronic Vascular | 1979-11-15 | Traditional | PDF ↗ |
| K791921 | CARDIAC PACEMAKER C4000, C1000 SER. | Vitatron Medical BV | 1979-10-26 | Traditional | PDF ↗ |
| K792052 | IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD | Telectronics, Inc. | 1979-10-22 | Traditional | PDF ↗ |
| K791783 | OMNI-STANICOR (THETA) MOD 237A | Cordis Corp. | 1979-10-22 | Traditional | PDF ↗ |
| K790792 | PULSE GENERATOR MODEL 637 | Elema-Schonander, Inc. | 1979-10-12 | Traditional | PDF ↗ |
| K790068 | PULSE GENERATORS, MODELS 5983, 5989 | Medtronic Vascular | 1979-09-28 | Traditional | PDF ↗ |
| K791784 | CORDIS BIPOLAR PACER CONNECTOR SYSTEM | Cordis Corp. | 1979-09-28 | Traditional | PDF ↗ |
| K791715 | ARCOLITH 2000 | Arco Medical Products Co. | 1979-09-27 | Traditional | PDF ↗ |
| K791727 | IMPLANTABLE VENTRICULAR-INHIBITED | Telectronics, Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | Edwards Pacemaker Systems | 1979-09-26 | Traditional | PDF ↗ |
| K791181 | PROGRAMMER, MEDTRONIC MODEL 5984/5985 | Medtronic Vascular | 1979-09-20 | Traditional | PDF ↗ |
| K790873 | MODEL 221 PROGRAMALITH PULSE GENERATOR | Pacesetter Systems | 1979-09-20 | Traditional | PDF ↗ |
| K791568 | IMPLANTABLE PULSE GENERATOR PACEMAKERS | Intermedics, Inc. | 1979-09-19 | Traditional | PDF ↗ |
| K791379 | MODEL 228-02 THINLITH II PACEMAKER, BIPO | Intermedics, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791678 | LITHICRON II 0403 IMPLANTABLE PACEMAKER | Medcor, Inc. | 1979-09-07 | Traditional | PDF ↗ |
| K791417 | IMPLANTABLE PULSE GENERATOR PACEMAKER | Intermedics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791095 | LITHICRON MODEL 0401, PACEMAKER | Medcor, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K790428 | MDL-201A & T DL-201A PULSE GENERATOR | Pacesetter Systems | 1979-08-10 | Traditional | PDF ↗ |
| K791225 | BJORK-SHILEY AORTIC GRAFT VALVE PROSTH | Shiley, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K790141 | PULSE GENERATOR, R WAVE DEMAND | Pacesetter Systems | 1979-08-10 | Traditional | PDF ↗ |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | Arco Medical Products Co. | 1979-08-03 | Traditional | PDF ↗ |
| K790446 | OVALITH-300 | Coratomic, Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K791219 | UNILITH PULSE GENERATOR | Ela Medical, Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K782161 | PULSE GENERATOR, MODEL 171 | Telectronics, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K782162 | BATTERY CHARGER, 171 PACEMAKER | Telectronics, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791165 | ARCOLITH 4000 | Arco Medical Products Co. | 1979-07-10 | Traditional | PDF ↗ |
| K790670 | PULSE GENERATOR MODEL 629 | Elema-Schonander, Inc. | 1979-06-27 | Traditional | PDF ↗ |
| K791093 | MODELS 2411/2418 VENTRICULAR-INHIBITED | Medtronic Vascular | 1979-06-20 | Traditional | PDF ↗ |
| K790666 | VITALITH S 3000 SERIES | Vitatron Medical BV | 1979-06-01 | Traditional | PDF ↗ |
| K790867 | CARDIAC PULSE GENERATOR, 16 SERIES | Telectronics, Inc. | 1979-05-31 | Traditional | PDF ↗ |
| K790868 | GENERATOR, 16 SERIES, MODIFIED TOP CAP | Telectronics, Inc. | 1979-05-25 | Traditional | PDF ↗ |
| K790690 | OMNI-STANICOR-(THETA) MODEL 217 | Cordis Corp. | 1979-05-16 | Traditional | PDF ↗ |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | Edwards Pacemaker Systems | 1979-05-08 | Traditional | PDF ↗ |
| K790562 | PULSE GENERATOR MODEL 61 AND 128 | Ela Medical, Inc. | 1979-05-08 | Traditional | PDF ↗ |
| K790764 | PACEMAKERS WITHOUT SILASTIC COATING | Telectronics, Inc. | 1979-04-26 | Traditional | PDF ↗ |
| K781973 | CARDIOPHONE | North American Motronic | 1979-03-21 | Traditional | PDF ↗ |
| K790432 | MICROLITH MODELS 505;605;507;607;703;803 | Cardiac Pacemakers, Inc. | 1979-03-20 | Traditional | PDF ↗ |
| K790566 | PACEMAKER, OVALITH-D CARDIAC | Caratomic | 1979-03-19 | Traditional | PDF ↗ |
| K790276 | MINILITH AND MICROLITH | Cardiac Pacemakers, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K790014 | BIPOLAR, STANICOR LAMBDA MODEL 236,235 | Cordis Corp. | 1979-02-08 | Traditional | PDF ↗ |
| K782149 | PULSE GENERATOR, IMPLANTABLE CARDIAC | Telectronics, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K790100 | ISOLATION SLEEVE, MODEL 348-01 | Intermedics, Inc. | 1979-01-24 | Traditional | PDF ↗ |
| K790099 | ISOLATION SLEEVE, MODEL 347-01 | Intermedics, Inc. | 1979-01-24 | Traditional | PDF ↗ |
| K790098 | ISOLATION SLEEVE, MODEL 349-01 | Intermedics, Inc. | 1979-01-24 | Traditional | PDF ↗ |
| K790101 | ISOLATION SLEEVE, MODEL 346-01 | Intermedics, Inc. | 1979-01-24 | Traditional | PDF ↗ |
| K782146 | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT | Arco Medical Products Co. | 1978-12-27 | Traditional | PDF ↗ |
| K782022 | MICROLITH A MODEL 703 | Cardiac Pacemakers, Inc. | 1978-12-22 | Traditional | PDF ↗ |
| K782023 | MICROLITH A MODEL 803 | Cardiac Pacemakers, Inc. | 1978-12-22 | Traditional | PDF ↗ |
| K780430 | LITHICRON F PROGRAMMABLE PULSE GEN | Medcor, Inc. | 1978-12-22 | Traditional | PDF ↗ |
| K781835 | PULSTRON MODEL 100 | Micro-Rel | 1978-12-21 | Traditional | PDF ↗ |
| K781738 | PACEMAKER, MODEL 229-01 | Intermedics, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K780897 | GENERATOR, PULSE, SORIN MODEL DL-1 | Bentley Laboratories, Inc. | 1978-12-06 | Traditional | PDF ↗ |
| K781377 | OVALITH 10BP | Coratomic, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K780776 | ARCOBIOLITH PACEMAKER MODEL | Arco Medical Products Co. | 1978-10-03 | Traditional | PDF ↗ |
| K781252 | GENERATOR, PULSE, MODEL 5997 | Medtronic Vascular | 1978-10-03 | Traditional | PDF ↗ |
| K781208 | GENERATORS, PULSE, MODELS 5988/5989 | Medtronic Vascular | 1978-10-03 | Traditional | PDF ↗ |
| K780940 | GENERATOR, PULSE, MODEL 160B | Telectronics, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K772226 | PACEMAKER, MODEL 225 & 227 | Intermedics, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K781424 | GENERATORS: UDL-201B, BDL-201B, MDL-201B | Pacesetter Systems | 1978-09-27 | Traditional | PDF ↗ |
| K781090 | GENERATOR, CARDIAC PULSE, 250B | Telectronics, Inc. | 1978-09-07 | Traditional | PDF ↗ |
| K781426 | CARDIAL PULSE GENERATORS | Telectronics, Inc. | 1978-09-07 | Traditional | PDF ↗ |
| K781178 | PULSE GENERATOR MODEL 208 | Elema-Schonander, Inc. | 1978-09-07 | Traditional | PDF ↗ |
| K781168 | GENERATOR, PULSE, PACEMAKER | Vitatron Medical BV | 1978-08-31 | Traditional | PDF ↗ |
Product code DXY · Class III · Cardiovascular. Data: openFDA.