FDA Product Code
FDA Product Code DTC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3630
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170815 | PSA Cable | Boston Scientific Corporation | 2017-07-06 | Traditional | PDF ↗ |
| K083674 | PK-141 PATIENT CABLE | Biotronik, Inc. | 2009-04-01 | Traditional | PDF ↗ |
| K011729 | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | Dni Nevada, Inc. | 2001-08-30 | Traditional | PDF ↗ |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | Pace Medical | 2000-10-10 | Traditional | PDF ↗ |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | North American Technical Services Corp. | 1996-11-08 | Traditional | PDF ↗ |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | Bio-Tek Instruments, Inc. | 1991-06-19 | Traditional | PDF ↗ |
| K910595 | MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1991-05-07 | Traditional | PDF ↗ |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | Seamed Corp. | 1991-03-19 | Traditional | PDF ↗ |
| K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | Biotronik, GmbH & Co. | 1990-05-09 | Traditional | PDF ↗ |
| K896632 | MEDTRONIC MODEL 5401B TEST CABLE | Medtronic Vascular | 1989-12-13 | Traditional | PDF ↗ |
| K884331 | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1989-01-10 | Traditional | PDF ↗ |
| K882327 | PACER SENSING ANALYZER (PSA 100) | Oscor Medical Corp. | 1988-10-06 | Traditional | PDF ↗ |
| K860462 | SEAMED MODEL 3000 | Seamed Corp. | 1986-08-19 | Traditional | PDF ↗ |
| K851900 | SEA MED DDD PACING SYSTEM ANALYZER | Seamed Corp. | 1985-07-19 | Traditional | PDF ↗ |
| K850077 | MEDTRONIC 5311 PACING SYSTEM ANALYZER | Medtronic Vascular | 1985-07-16 | Traditional | PDF ↗ |
| K844969 | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | Cordis Corp. | 1985-05-01 | Traditional | PDF ↗ |
| K831697 | TELECTRONICS MODEL 2401 | Seamed Corp. | 1984-09-04 | Traditional | PDF ↗ |
| K812262 | MEDTRONIC A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1982-06-17 | Traditional | PDF ↗ |
| K810604 | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | Telectronics, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR | Ela Medical, Inc. | 1980-03-25 | Traditional | PDF ↗ |
| K800286 | CRITERION II PACING SYSTEM MONITORS | Dart Medical Equipment | 1980-03-12 | Traditional | PDF ↗ |
| K791975 | PACING SYSTEM ANALYZER PSA SCE-22 | Ela Medical, Inc. | 1980-01-31 | Traditional | PDF ↗ |
| K792074 | MODEL 674 PACER ANALYZER | Del Mar Avionics | 1979-12-27 | Traditional | PDF ↗ |
| K791762 | SELF CHECK | Instromedix, Inc. | 1979-09-21 | Traditional | PDF ↗ |
| K781349 | PACER-TRACER PULSE WIDTH | Instromedix, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | Edwards Pacemaker Systems | 1978-08-23 | Traditional | PDF ↗ |
| K780717 | EXTERNAL TEST PULSE GENERATOR | Vitatron Medical BV | 1978-06-30 | Traditional | PDF ↗ |
| K771922 | MINICLINIC TM | Instromedix, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K770865 | MONITOR, PACEMAKER | Adcor Electronics, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K760013 | PACER SYSTEMS ANALYZER (CORDIS) | Cordis Corp. | 1976-07-20 | Traditional | PDF ↗ |
Product code DTC · Class II · Cardiovascular. Data: openFDA.