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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K833199 | SILICONE RUBBER ISOLATION SLEEVE 350-01 | Intermedics, Inc. | 1983-10-28 | Traditional | PDF ↗ |
| K831860 | GENERATOR, PULSE, PACEMAKER #532 | Vitatron Medical BV | 1983-10-27 | Traditional | PDF ↗ |
| K831859 | PACEMAKER PROGRAMMER #2032 | Vitatron Medical BV | 1983-10-27 | Traditional | PDF ↗ |
| K833198 | SILICONE RUBBER ISOLATION SLEEVE 351-01 | Intermedics, Inc. | 1983-10-27 | Traditional | PDF ↗ |
| K831633 | QUANTUM BIPOLAR CARDIAC PULSE GENERATOR | Intermedics, Inc. | 1983-10-12 | Traditional | PDF ↗ |
| K832893 | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI | Cook Pacemaker Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K831771 | IMPLANTABLE PROGRAM. CARDIAC PULSE GEN | Telectronics, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K832052 | MODEL 327T UNIPOLAR CARDIAC PULSE GEN | Cook Pacemaker Corp. | 1983-08-08 | Traditional | PDF ↗ |
| K831216 | COMMAND ULTRA II | Cardiac Pacemakers, Inc. | 1983-07-12 | Traditional | PDF ↗ |
| K831161 | COMMAND ULTRA I | Cardiac Pacemakers, Inc. | 1983-06-15 | Traditional | PDF ↗ |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | Burditt & Calkins-Siemens-Elema | 1983-05-27 | Traditional | PDF ↗ |
| K830862 | NEDS-01 & EPR-500 | Biotronik Sales, Inc. | 1983-05-25 | Traditional | PDF ↗ |
| K830390 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | Telectronics, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823878 | IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 | Pacesetter Systems | 1983-03-24 | Traditional | PDF ↗ |
| K830382 | COMMAND ULTRA II | Cardiac Pacemakers, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830401 | UNILITH PULSE GENERATOR VVI #7542 | Ela Medical, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K823831 | MEDTRONIC MODELS 59401 5941 | Medtronic Vascular | 1983-03-16 | Traditional | PDF ↗ |
| K823863 | CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC | Intermedics, Inc. | 1983-03-10 | Traditional | PDF ↗ |
| K822639 | AFP SYSTEM PULSE GENERATOR MODEL 261/262 | Pacesetter Systems | 1983-02-18 | Traditional | PDF ↗ |
| K823559 | AFP PULSE GENERATOR | Pacesetter Systems | 1983-02-18 | Traditional | PDF ↗ |
| K823371 | DURAPULSE | Cpm International, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K823678 | TELEMETRY DECODER #540-02 | Intermedics, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | Coratomic, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K822907 | KALOS-03 BIPOLAR | Biotronik Sales, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822904 | MODEL 325D UNIPOLAR CARDIAC PULSE GEN | Cook Pacemaker Corp. | 1982-10-15 | Traditional | PDF ↗ |
| K822297 | ENERTRAX MODEL 7100E | Medtronic Vascular | 1982-10-04 | Traditional | PDF ↗ |
| K822309 | COMMAND NP | Cardiac Pacemakers, Inc. | 1982-10-04 | Traditional | PDF ↗ |
| K822652 | JAIN INSULATING BOOT MODEL 225B | Cook Pacemaker Corp. | 1982-10-04 | Traditional | PDF ↗ |
| K822147 | MEDTRONIC ENERTRAX MODEL 7100 | Medtronic Vascular | 1982-08-06 | Traditional | PDF ↗ |
| K820939 | C-101-P | Coratomic, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K821014 | CORATOMIC MODEL OVALITH 920BP | Coratomic, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K821033 | CORATOMIC MODEL OVALITH-920 | Coratomic, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K821073 | PULSE GENERATOR | Biotronik Sales, Inc. | 1982-05-07 | Traditional | PDF ↗ |
| K821003 | PROGRAMMALITH II, #225 & 226 | Pacesetter Systems | 1982-05-07 | Traditional | PDF ↗ |
| K821147 | COOK #326T PROGRAM/TELEMETRY BIPOLAR | Cook Pacemaker Corp. | 1982-05-07 | Traditional | PDF ↗ |
| K820657 | PULSE GENERATOR 678 B | Siemens Elema AB | 1982-04-15 | Traditional | PDF ↗ |
| K820853 | QUANTUM MODELS 253-09, 254-09 254-10 | Intermedics, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K820774 | IMPLANTABLE, MULTIPROGRAMMABLE | Biotronik Sales, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K820356 | MULTICOR (GAMMA) 402 CARDIAC PACER | Cordis Corp. | 1982-03-18 | Traditional | PDF ↗ |
| K820231 | COMMAND ULTRA I | Cardiac Pacemakers, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K813246 | MEDICAL MULTILITH PULSE GENERA-1140 | Ela Medical, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K813576 | SIEMENS-ELEMA PULSE GENERATOR 659 | Siemens Elema AB | 1982-01-22 | Traditional | PDF ↗ |
| K813534 | COMMAND P5 | Cardiac Pacemakers, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K812610 | SIEMENS-ELEMA PULSE GENERATOR 668 B | Siemens Corp. | 1981-12-10 | Traditional | PDF ↗ |
| K813079 | BIPOLAR OPTIMA MP #255 | Telectronics, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K813150 | DIRECTIONAL BOOT | Pacesetter Systems | 1981-12-02 | Traditional | PDF ↗ |
| K813101 | CARDIOBEEPER MEMORY MONITOR | Survival Technology, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K812464 | SYNTHEMED PULSE GENERATOR VVI MODEL 1000 | Synthemed Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K812832 | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. | Cook Pacemaker Corp. | 1981-11-05 | Traditional | PDF ↗ |
| K812358 | MODEL 325T PROGRAMMABLE PULSE GENERATOR | Cook Pacemaker Corp. | 1981-10-29 | Traditional | PDF ↗ |
| K812790 | IMPLANTABLE VENTRICULAR-INHIBITED CARDI | Telectronics, Inc. | 1981-10-29 | Traditional | PDF ↗ |
| K812218 | KALOS-03 | Biotronik Sales, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K801337 | CYBERLITH IX IMPLANTABLE PULSE GENERATOR | Intermedics, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K812580 | MEDTRONIC MODEL 2409 | Medtronic Vascular | 1981-09-23 | Traditional | PDF ↗ |
| K801339 | TELEMETRY DECODER | Intermedics, Inc. | 1981-09-23 | Traditional | PDF ↗ |
| K812096 | MEDTRONIC ENERTRAX MODEL 7100 | Medtronic Vascular | 1981-09-16 | Traditional | PDF ↗ |
| K812153 | MEDTRONIC SPECTRAX | Medtronic Vascular | 1981-08-31 | Traditional | PDF ↗ |
| K811402 | COMMAND P5(BIPOLAR PULSE GENERATOR) | Cardiac Pacemakers, Inc. | 1981-07-27 | Traditional | PDF ↗ |
| K810887 | ELA MEDICAL UNILITH 7540 PULSE GENERATOR | Ela Medical, Inc. | 1981-07-20 | Traditional | PDF ↗ |
| K811691 | CORDIS OMNI-ARTICOR CARDIAC PACER #308 | Cordis Corp. | 1981-07-20 | Traditional | PDF ↗ |
| K811768 | CORATOMIC MODEL OVALITH-920BP | Corptomic | 1981-07-20 | Traditional | PDF ↗ |
| K811350 | UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. | Medtronic Vascular | 1981-07-01 | Traditional | PDF ↗ |
| K810885 | #326 PROGRAMMABLE CARD. PULSE GENERATOR | Cook Pacemaker Corp. | 1981-06-16 | Traditional | PDF ↗ |
| K810884 | #325 PROGRAMMABLE CARD. PULSE GENERATOR | Cook Pacemaker Corp. | 1981-06-16 | Traditional | PDF ↗ |
| K810489 | MULTILITH PULSE GENERATOR #1140 | Ela Medical, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K810142 | ELA MEDICAL UNILITH PULSE GENERATOR | Ela Medical, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K811221 | INTERMEDICS CYBERLITH BIPOLAR CARDIAC | Intermedics, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K811123 | MEDTRONIC PULSE GENERATOR | Medtronic Vascular | 1981-05-27 | Traditional | PDF ↗ |
| K810677 | MODELS 5976/5977 PACEMAKER PULSE GENER | Medtronic, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K810734 | MODELS 8420 THRU 8423 PACEMAKER GENER | Medtronic Vascular | 1981-05-15 | Traditional | PDF ↗ |
| K810808 | CORATOMIC MODEL OVALITH-920 | Coratomic, Inc. | 1981-05-15 | Traditional | PDF ↗ |
| K810752 | THINLITH III UNIPOLAR CARDIAC PULSE GEN. | Intermedics, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K810800 | MODEL 230-05 CYBERLITH I BIPOL. PULSE G. | Intermedics, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K811066 | MODEL 230-06 CYBERLITH TM I BIPOLAR IN | Intermedics, Inc. | 1981-05-01 | Traditional | PDF ↗ |
| K810901 | INSULATIVE COATING FOR CARD. PULSE GEN | Intermedics, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810603 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE | Telectronics, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810383 | INTERMEDICS CYBERLITH I BIOPOLAR CARDI | Intermedics, Inc. | 1981-04-01 | Traditional | PDF ↗ |
| K810385 | CYBERLITH I PULSE GENERATOR MODEL 253-04 | Intermedics, Inc. | 1981-04-01 | Traditional | PDF ↗ |
| K810386 | THINLITH II PULSE GNEERATOR MODEL 227-05 | Intermedics, Inc. | 1981-03-13 | Traditional | PDF ↗ |
| K810410 | STERILE PACKAGING | Telectronics, Inc. | 1981-03-05 | Traditional | PDF ↗ |
| K810121 | UNIFOCAL 3 | American Pacemaker Corp. | 1981-02-23 | Traditional | PDF ↗ |
| K801584 | MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. | Medtronic Vascular | 1981-02-12 | Traditional | PDF ↗ |
| K802864 | SIEMENS-ELEMA PULSE GENERATOR 678 | Siemens Elema AB | 1981-02-05 | Traditional | PDF ↗ |
| K810036 | SIEMENS-ELEMA MYOCARDIAL LEAD | Siemens Elema AB | 1981-01-29 | Traditional | PDF ↗ |
| K803197 | IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 | Telectronics, Inc. | 1981-01-22 | Traditional | PDF ↗ |
| K801338 | CYBERLITH PROGRAMMER | Intermedics, Inc. | 1981-01-07 | Traditional | PDF ↗ |
| K803035 | MICROTHIN-PII BIPOLAR PULSE GEN. #0621 | Cardiac Pacemakers, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802353 | MICRO THIN-PII, #0523 | Cardiac Pacemakers, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K803034 | MICROTHIN-PII BIPOLAR PULSE GEN. #0623 | Cardiac Pacemakers, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802352 | MICRO THIN-DII, #0521 | Cardiac Pacemakers, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 | American Pacemaker Corp. | 1980-12-16 | Traditional | PDF ↗ |
| K801324 | SIEMENS-ELEMA PULSE GENERATOR 668 | Siemens Elema AB | 1980-12-01 | Traditional | PDF ↗ |
| K792609 | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. | Medcor, Inc. | 1980-11-19 | Traditional | PDF ↗ |
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | Arco Medical Products Co. | 1980-11-19 | Traditional | PDF ↗ |
| K802409 | MICROTHIN-DI BIPOLAR PULSE GENERATOR | Cardiac Pacemakers, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K802410 | MICROTHIN-PI BIPOLAR PULSE GENERATOR | Cardiac Pacemakers, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801640 | SORIN PULSE GENERATOR, MODEL #LIT-214 | Bentley Laboratories, Inc. | 1980-10-03 | Traditional | PDF ↗ |
| K801978 | PROGRAMALITH #'S 221, 222, 221A & 222A | Pacesetter Systems | 1980-09-26 | Traditional | PDF ↗ |
| K802028 | IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN | Telectronics, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) | American Pacemaker Corp. | 1980-09-26 | Traditional | PDF ↗ |
Product code DXY · Class III · Cardiovascular. Data: openFDA.