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 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K780741 | GENERATOR, PULSE, DEMAND, MODEL 5996 | Medtronic Vascular | 1978-07-28 | Traditional | PDF ↗ |
| K780809 | GENERATOR, PULSE MODELS 5920/5921 | Medtronic Vascular | 1978-07-28 | Traditional | PDF ↗ |
| K780781 | STILITH CARDIAC PACEMAKERS-M. 60 & 120 | R.E. Brown Co., Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K780561 | VENTRICULAR INHIBITED PULSE GENERATOR | Medtronic Vascular | 1978-07-27 | Traditional | PDF ↗ |
| K780420 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | Telectronics, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K781042 | PROLITH 23S PACEMAKER | Edwards Pacemaker Systems | 1978-07-27 | Traditional | PDF ↗ |
| K780421 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | Telectronics, Inc. | 1978-07-07 | Traditional | PDF ↗ |
| K780453 | STANICOR THETA MODEL 221 CARDIAC PACER | Cordis Corp. | 1978-06-30 | Traditional | PDF ↗ |
| K780780 | MICROPULSE 22S PACEMAKER | Edwards Pacemaker Systems | 1978-06-30 | Traditional | PDF ↗ |
| K780327 | GENERATORS, ATRIAL INHIBITED PULSE | Medtronic Vascular | 1978-05-18 | Traditional | PDF ↗ |
| K780777 | BAGS, PLASTIC, STERILE FOR GENERATORS | Telectronics, Inc. | 1978-05-16 | Traditional | PDF ↗ |
| K780437 | PACEMAKER, MODEL 252, C-MOS | Intermedics, Inc. | 1978-04-05 | Traditional | PDF ↗ |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | Edwards Pacemaker Systems | 1978-03-15 | Traditional | PDF ↗ |
| K780113 | CARDIAC PULSE GENERATOR, MODEL 160B | Telectronics, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K780091 | MICROPULSE 22U | Edwards Pacemaker Systems | 1978-01-30 | Traditional | PDF ↗ |
| K772238 | PULSE GENERATOR, UNIPOLAR, PROGRAMABLE | Cardiac Pacemakers, Inc. | 1978-01-30 | Traditional | PDF ↗ |
| K772050 | TDL-100 B | Pacesetter Systems | 1978-01-30 | Traditional | PDF ↗ |
| K772240 | PULSE GENERATOR, UNIPOLAR, DEMAND | Cardiac Pacemakers, Inc. | 1978-01-30 | Traditional | PDF ↗ |
| K772239 | PULSE GENERATOR, BIPOLAR, PROGRAMMABLE | Cardiac Pacemakers, Inc. | 1978-01-30 | Traditional | PDF ↗ |
| K780066 | CARDIAC PACER, MODEL 208 | Cordis Corp. | 1978-01-30 | Traditional | PDF ↗ |
| K772051 | MDL-201 | Pacesetter Systems | 1978-01-30 | Traditional | PDF ↗ |
| K772241 | PULSE GENERATOR, BIPOLAR, DEMAND | Cardiac Pacemakers, Inc. | 1978-01-30 | Traditional | PDF ↗ |
| K780061 | PULSE GENERATORS, MODELS 5972/5973 | Medtronic Vascular | 1978-01-24 | Traditional | PDF ↗ |
| K772357 | PULSE GENERATORS | Medtronic Vascular | 1978-01-17 | Traditional | PDF ↗ |
| K771786 | CARDIAC PULSE GENERATORS 5982/5983 | Medtronic Vascular | 1978-01-04 | Traditional | PDF ↗ |
| K771770 | XYREL-RA MODELS 5994/5995 | Medtronic Vascular | 1978-01-04 | Traditional | PDF ↗ |
| K772202 | PULSE GENERATOR, A-V SEQ. | Medtronic Vascular | 1977-12-20 | Traditional | PDF ↗ |
| K772009 | CARDIAC PACEMAKER S6001 | Vitatron Medical BV | 1977-11-28 | Traditional | PDF ↗ |
| K772010 | CARDIAC PACEMAKER C2001 | Vitatron Medical BV | 1977-11-28 | Traditional | PDF ↗ |
| K772057 | BIPOLAR PACEMAKER MODEL 224 | Intermedics, Inc. | 1977-11-03 | Traditional | PDF ↗ |
| K772026 | CARDIAC PULSE GENERATOR, MODEL 150L | Telectronics, Inc. | 1977-11-03 | Traditional | PDF ↗ |
| K771992 | L-501 CARDIAC PACEMAKER | Coratomic, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771987 | MICROPULSE 26U PULSE GENERATOR | Edwards Pacemaker Systems | 1977-11-02 | Traditional | PDF ↗ |
| K771626 | PACEMAKER MODEL 251 | Intermedics, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771670 | IMPLANTED PACEMAKER PLUSE GENERATOR | Telectronics, Inc. | 1977-09-12 | Traditional | PDF ↗ |
| K771538 | LITHICRON MODEL 3-70C-B PULSE GENERATOR | Medcor, Inc. | 1977-08-22 | Traditional | PDF ↗ |
| K771262 | PACEMAKER & CARDIAC LEAD, BIPOLAR | Arco Medical Products Co. | 1977-07-21 | Traditional | PDF ↗ |
| K770881 | GENERATOR, PULSE, BIPOLAR 3608 | Cardiac Pacemakers, Inc. | 1977-06-20 | Traditional | PDF ↗ |
| K770880 | GENERATOR, PULSE, UNIPOLAR, #508 | Cardiac Pacemakers, Inc. | 1977-06-20 | Traditional | PDF ↗ |
| K770951 | CARDIAC PACERS W/NARROW PULSE WIDTH | Cordis Corp. | 1977-06-20 | Traditional | PDF ↗ |
| K770716 | GENERATOR, PULSE, UNIPOLAR, MODEL #504 | Cardiac Pacemakers, Inc. | 1977-04-26 | Traditional | PDF ↗ |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | Edwards Pacemaker Systems | 1977-04-26 | Traditional | PDF ↗ |
| K770656 | GENERATOR, PULSE, CARDIAC 20U | Edwards Pacemaker Systems | 1977-04-26 | Traditional | PDF ↗ |
| K770661 | GENERATOR, PULSE, IMPLANTABLE | Med Telectronics , Ltd. | 1977-04-26 | Traditional | PDF ↗ |
| K770715 | GENERATOR, PULSE, BIPOLAR, MODEL #604 | Cardiac Pacemakers, Inc. | 1977-04-25 | Traditional | PDF ↗ |
| K770507 | PULSE GENERATOR, LITKICRON MODEL 3-70H | Medcor, Inc. | 1977-04-07 | Traditional | PDF ↗ |
| K770419 | CENTURION | Johnson & Johnson Professionals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K770559 | C-L0L CARDIAC PACEMAKER | Coratomic, Inc. | 1977-03-28 | Traditional | PDF ↗ |
| K770212 | PROLITH MODEL 21S CARDIAC PULSE GEN. | Edwards Pacemaker Systems | 1977-03-09 | Traditional | PDF ↗ |
| K770211 | MICROPULSE MODEL 20S | Edwards Pacemaker Systems | 1977-03-07 | Traditional | PDF ↗ |
| K770328 | PACEMAKER, ANTRIO-VENTRICULAR SEQ. | American Pacemaker Corp. | 1977-02-28 | Traditional | PDF ↗ |
| K770005 | PACEMAKER 208S | Elema-Schonander, Inc. | 1977-02-24 | Traditional | PDF ↗ |
| K770135 | LEAD MODIFICATION | Elema-Schonander, Inc. | 1977-02-07 | Traditional | PDF ↗ |
| K770197 | UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR | Cardiac Pacemakers, Inc. | 1977-02-07 | Traditional | PDF ↗ |
| K770198 | BIPOLAR ASYNCHRONOUS PULSE GENERATOR | Cardiac Pacemakers, Inc. | 1977-02-07 | Traditional | PDF ↗ |
| K761143 | LITHIUM IODIDE BATTERY PACEMAKER (#201) | Pacesetter Systems | 1976-12-23 | Traditional | PDF ↗ |
| K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | Arco Medical Products Co. | 1976-12-21 | Traditional | PDF ↗ |
| K760669 | PACEMAKERS, VITATRON'S | Vitatron Medical BV | 1976-11-12 | Traditional | PDF ↗ |
| K760671 | PACEMAKERS, VITATRONS (SERIES 3000) | Vitatron Medical BV | 1976-11-12 | Traditional | PDF ↗ |
| K760670 | PACEMAKERS, VITATRONS (SERIES 2000) | Vitatron Medical BV | 1976-11-12 | Traditional | PDF ↗ |
| K760757 | MODEL 100 CARDIAC PACEMAKER | Pacesetter Systems | 1976-11-11 | Traditional | PDF ↗ |
Product code DXY · Class III · Cardiovascular. Data: openFDA.