Product code DTC
- Device name
- Analyzer, Pacemaker Generator Function
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3630
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170815 | PSA Cable | Boston Scientific Corporation | 2017-07-06 |
| K083674 | PK-141 PATIENT CABLE | Biotronik, Inc. | 2009-04-01 |
| K011729 | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | Dni Nevada, Inc. | 2001-08-30 |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | Pace Medical | 2000-10-10 |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | North American Technical Services Corp. | 1996-11-08 |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | Bio-Tek Instruments, Inc. | 1991-06-19 |
| K910595 | MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1991-05-07 |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | Seamed Corp. | 1991-03-19 |
| K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | Biotronik, GmbH & Co. | 1990-05-09 |
| K896632 | MEDTRONIC MODEL 5401B TEST CABLE | Medtronic Vascular | 1989-12-13 |
| K884331 | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1989-01-10 |
| K882327 | PACER SENSING ANALYZER (PSA 100) | Oscor Medical Corp. | 1988-10-06 |
| K860462 | SEAMED MODEL 3000 | Seamed Corp. | 1986-08-19 |
| K851900 | SEA MED DDD PACING SYSTEM ANALYZER | Seamed Corp. | 1985-07-19 |
| K850077 | MEDTRONIC 5311 PACING SYSTEM ANALYZER | Medtronic Vascular | 1985-07-16 |
| K844969 | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | Cordis Corp. | 1985-05-01 |
| K831697 | TELECTRONICS MODEL 2401 | Seamed Corp. | 1984-09-04 |
| K812262 | MEDTRONIC A-V PACING SYSTEM ANALYZER | Medtronic Vascular | 1982-06-17 |
| K810604 | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | Telectronics, Inc. | 1981-04-14 |
| K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR | Ela Medical, Inc. | 1980-03-25 |
| K800286 | CRITERION II PACING SYSTEM MONITORS | Dart Medical Equipment | 1980-03-12 |
| K791975 | PACING SYSTEM ANALYZER PSA SCE-22 | Ela Medical, Inc. | 1980-01-31 |
| K792074 | MODEL 674 PACER ANALYZER | Del Mar Avionics | 1979-12-27 |
| K791762 | SELF CHECK | Instromedix, Inc. | 1979-09-21 |
| K781349 | PACER-TRACER PULSE WIDTH | Instromedix, Inc. | 1978-08-31 |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | Edwards Pacemaker Systems | 1978-08-23 |
| K780717 | EXTERNAL TEST PULSE GENERATOR | Vitatron Medical BV | 1978-06-30 |
| K771922 | MINICLINIC TM | Instromedix, Inc. | 1977-11-02 |
| K770865 | MONITOR, PACEMAKER | Adcor Electronics, Inc. | 1977-06-14 |
| K760013 | PACER SYSTEMS ANALYZER (CORDIS) | Cordis Corp. | 1976-07-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B33596020000 | External Pacemaker Analyzer | NETECH CORPORATION | 2024-08-23 |
| B3359600 | External Pacemaker Analyzer | NETECH CORPORATION | 2023-07-03 |
| 00763000688400 | CareLink SmartSync™ | MEDTRONIC, INC. | 2022-10-28 |
| 04035479092443 | PK-141/2.8m | BIOTRONIK SE & Co. KG | 2021-05-06 |
| 00763000201289 | CareLink SmartSync™ | MEDTRONIC, INC. | 2019-06-01 |
| 00763000002039 | CareLink SmartSync™ Azure Astra Application | MEDTRONIC, INC. | 2019-04-06 |
| 00643169957657 | CareLink SmartSync™ | MEDTRONIC, INC. | 2019-03-30 |
| 00850540007157 | SigmaPace 1000 | FLUKE ELECTRONICS CORPORATION | 2018-05-24 |
| 00802526580208 | NA | BOSTON SCIENTIFIC CORPORATION | 2017-11-16 |
| B3359500 | External Pacemaker Ananlyzer | NETECH CORPORATION | 2017-06-16 |
| 00643169833715 | CareLink SmartSync™ Common Application | MEDTRONIC, INC. | 2017-05-25 |
| 00643169833739 | CareLink SmartSync™ Common Application | MEDTRONIC, INC. | 2017-05-25 |
| 00643169833753 | CareLink SmartSync™ PSA Application | MEDTRONIC, INC. | 2017-05-25 |
| 00643169868540 | CareLink SmartSync™ | MEDTRONIC, INC. | 2017-05-25 |