Analyzer, Pacemaker Generator Function
FDA product code DTC · Class II (moderate risk) · 21 CFR 870.3630 · Cardiovascular
30510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Medtronic Vascular 5
- Seamed Corp. 4
- Instromedix, Inc. 3
- Cordis Corp. 2
- Ela Medical, Inc. 2
- Biotronik, Inc. 2
- Boston Scientific Corporation 1
- Dni Nevada, Inc. 1
- Pace Medical 1
- North American Technical Services Corp. 1
- Bio-Tek Instruments, Inc. 1
- Oscor Medical Corp. 1
- Telectronics, Inc. 1
- Dart Medical Equipment 1
- Del Mar Avionics 1
- Edwards Pacemaker Systems 1
- Vitatron Medical BV 1
- Adcor Electronics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
| K884331 | Medtronic Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 01/10/1989SE |
| K882327 | Pacer Sensing Analyzer (Psa 100)DTC · Traditional | Oscor Medical Corp. | 10/06/1988SE |
| K860462 | Seamed Model 3000DTC · Traditional | Seamed Corp. | 08/19/1986SE |
| K851900 | Sea Med DDD Pacing System AnalyzerDTC · Traditional | Seamed Corp. | 07/19/1985SE |
| K850077 | Medtronic 5311 Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 07/16/1985SE |
| K844969 | Cordis Dual-Chamber Psa Model 296A (Pacemaker)DTC · Traditional | Cordis Corp. | 05/01/1985SE |
| K831697 | Telectronics Model 2401DTC · Traditional | Seamed Corp. | 09/04/1984SE |
| K812262 | Medtronic A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 06/17/1982SE |
| K810604 | Electrode/Pacer System Analyzer Pma 400DTC · Traditional | Telectronics, Inc. | 04/14/1981SE |
| K792602 | Susi II Pacemaker Surveillance MonitorDTC · Traditional | Ela Medical, Inc. | 03/25/1980SE |
| K800286 | Criterion II Pacing System MonitorsDTC · Traditional | Dart Medical Equipment | 03/12/1980SE |
| K791975 | Pacing System Analyzer Psa SCE-22DTC · Traditional | Ela Medical, Inc. | 01/31/1980SE |
| K792074 | Model 674 Pacer AnalyzerDTC · Traditional | Del Mar Avionics | 12/27/1979SE |
| K791762 | Self CheckDTC · Traditional | Instromedix, Inc. | 09/21/1979SE |
| K781349 | Pacer-Tracer Pulse WidthDTC · Traditional | Instromedix, Inc. | 08/31/1978SE |
| K781144 | Analyzer, Pacer System, PSA-5DTC · Traditional | Edwards Pacemaker Systems | 08/23/1978SE |
| K780717 | External Test Pulse GeneratorDTC · Traditional | Vitatron Medical BV | 06/30/1978SE |
| K771922 | Miniclinic TMDTC · Traditional | Instromedix, Inc. | 11/02/1977SE |
| K770865 | Monitor, PacemakerDTC · Traditional | Adcor Electronics, Inc. | 06/14/1977SE |
| K760013 | Pacer Systems Analyzer (Cordis)DTC · Traditional | Cordis Corp. | 07/20/1976SE |