FDA Product Code
FDA Product Code DTE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3600
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241781 | Solo Pace Control | Solo Pace, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024-01-07 | Special | PDF ↗ |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020-05-13 | Special | PDF ↗ |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019-04-30 | Special | PDF ↗ |
| K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 | Traditional | PDF ↗ |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-08-21 | Special | PDF ↗ |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-04-19 | Special | PDF ↗ |
| K162054 | Medtronic Temporary External Pacemaker 53401 | Medtronic, Inc. | 2016-10-18 | Traditional | PDF ↗ |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016-10-12 | Special | PDF ↗ |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015-02-18 | Special | PDF ↗ |
| K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | Medtronic, Inc. | 2013-10-31 | Traditional | PDF ↗ |
| K123916 | PSA SERIES | Osypka Medical, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K042708 | ERA 3000 PACING SYSTEM ANALYZER | Biotronik, Inc. | 2004-10-20 | Special | PDF ↗ |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | Osypka Medical, Inc. | 2003-10-31 | Special | PDF ↗ |
| K023080 | GALIX PACESTAR | Galix Biomedical Instrumentation, Inc. | 2003-06-11 | Traditional | PDF ↗ |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | Osypka Medical, Inc. | 2002-10-03 | Special | PDF ↗ |
| K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE | Osypka Medical, Inc. | 2002-06-14 | Abbreviated | PDF ↗ |
| K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | Pace Medical | 2001-09-12 | Traditional | PDF ↗ |
| K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | Pace Medical | 2000-10-18 | Traditional | PDF ↗ |
| K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | Pace Medical | 2000-06-27 | Traditional | PDF ↗ |
| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | Paladin Medical, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K971474 | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL | Medtronic Vascular | 1997-07-14 | Traditional | PDF ↗ |
| K964190 | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | 1997-07-10 | Traditional | PDF ↗ |
| K970497 | PACE 101H | Sulzer Oscor, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K960676 | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 | Zoll Medical Corp | 1996-06-05 | Traditional | PDF ↗ |
| K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 | Remington Medical, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K934016 | POWERCHARGER | Zoll Medical Corp | 1994-10-18 | Traditional | PDF ↗ |
| K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER | Pace Medical | 1994-09-27 | Traditional | PDF ↗ |
| K923621 | EXTERNAL DEMAND PACEMAKER | Oscor Medical Corp. | 1993-05-19 | Traditional | PDF ↗ |
| K923398 | CPI MODEL 2215 | Seamed Corp. | 1992-08-14 | Traditional | PDF ↗ |
| K915364 | CHRONOCOR VI MODEL 5012 | Seamed Corp. | 1992-02-07 | Traditional | PDF ↗ |
| K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER | Pace Medical | 1991-11-19 | Traditional | PDF ↗ |
| K912507 | CPI MODEL 2215 & SEAMED MODEL 3400 | Seamed Corp. | 1991-09-03 | Traditional | PDF ↗ |
| K910237 | MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR | Medtronic Vascular | 1991-02-25 | Traditional | PDF ↗ |
| K902679 | MODELS 4201, 4231 & 4235 EXTENSION CABLES | Pace Medical | 1990-07-19 | Traditional | PDF ↗ |
| K900220 | TRANS-PACE 100 | Synchromed Corp. | 1990-07-17 | Traditional | PDF ↗ |
| K896352 | MODEL EC4542G MINIATURE | Pace Medical | 1990-01-24 | Traditional | PDF ↗ |
| K893633 | MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE | Medtronic Vascular | 1989-06-20 | Traditional | PDF ↗ |
| K883930 | SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY | Seamed Corp. | 1988-11-09 | Traditional | PDF ↗ |
| K872551 | SEAMED MODEL 3200 | Seamed Corp. | 1987-07-31 | Traditional | PDF ↗ |
| K871915 | MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 | Pace Medical | 1987-06-10 | Traditional | PDF ↗ |
| K853194 | ERA-20 | Biotronik Sales, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K870323 | MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER | Pace Medical | 1987-03-03 | Traditional | PDF ↗ |
| K863903 | SEA MED MODEL 6000 | Seamed Corp. | 1986-12-10 | Traditional | PDF ↗ |
| K854648 | SEAMED MODEL 4000 | Seamed Corp. | 1986-01-16 | Traditional | PDF ↗ |
| K850822 | CHRONOCOR V EXTERNAL PACER, MODEL 297A | Seamed Corp. | 1985-07-16 | Traditional | PDF ↗ |
| K843777 | SEAMED 4000 | Seamed Corp. | 1985-02-01 | Traditional | PDF ↗ |
| K843807 | SEAMED MODEL 6000 | Seamed Corp. | 1985-02-01 | Traditional | PDF ↗ |
| K831768 | EXTERNAL PULSE GENERATOR FOR TEMP. STIM | Oscor, Inc. | 1983-12-16 | Traditional | PDF ↗ |
| K831381 | RAPID ATRIAL PACER | Seamed Corp. | 1983-08-31 | Traditional | PDF ↗ |
| K823048 | SEA MED MODEL 880 | Seamed Corp. | 1982-12-15 | Traditional | PDF ↗ |
| K821791 | EXTERNAL PULSE GENERATOR - EV4542 | American Pacemaker Corp. | 1982-07-06 | Traditional | PDF ↗ |
| K820570 | SEAMED, #540 - SIEMENS, #146F TELECTRO | Seamed Corp. | 1982-06-03 | Traditional | PDF ↗ |
| K811092 | STERILE PACKAGING | Telectronics, Inc. | 1981-07-01 | Traditional | PDF ↗ |
| K810566 | SIEMENS MODEL 146-146A EXTERNAL PULSE G | Cynergy | 1981-04-01 | Traditional | PDF ↗ |
| K803313 | PACING SYSTEM ANALYZER | Medtronic Vascular | 1981-02-23 | Traditional | PDF ↗ |
| K802221 | CHRONOCOR IV MODEL 250 | Cordis Corp. | 1980-11-19 | Traditional | PDF ↗ |
| K801055 | COMPUPACE, 524-01 PACER SYSTEM COMPUTER | Intermedics, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801953 | EXTERNAL, TEMP. PORTABLE CARDIAC GENER | Telectronics, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801596 | CYNERGY MODEL 184 | Cynergy | 1980-09-16 | Traditional | PDF ↗ |
| K792536 | CYNERGY MODEL 182 | Cynergy | 1980-01-31 | Traditional | PDF ↗ |
| K800088 | PACEMAKER ELECTRODE INSERTER AIDE | Telectronics, Inc. | 1980-01-29 | Traditional | PDF ↗ |
| K792223 | PACESETTER MODEL 350 | Cynergy | 1979-11-30 | Traditional | PDF ↗ |
| K782108 | MEDTRONIC MODEL 546 | Medtronic Vascular | 1978-12-29 | Traditional | PDF ↗ |
| K781327 | PULSE GENERATOR, MODEL 240, EXTERNAL | Intermedics, Inc. | 1978-12-11 | Traditional | PDF ↗ |
Product code DTE · Class II · Cardiovascular. Data: openFDA.