Panels › Cardiovascular › Product code DTC · Class 2
Analyzer, Pacemaker Generator Function
Regulation 870.3630
0510(k)s in 12 months (30 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DTC
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 5 | 0 |
| Seamed Corp. | 4 | 0 |
| Instromedix, Inc. | 3 | 0 |
| Biotronik, GmbH & Co. | 2 | 0 |
| Cordis Corp. | 2 | 0 |
| Ela Medical, Inc. | 2 | 0 |
| Adcor Electronics, Inc. | 1 | 0 |
| Bio-Tek Instruments, Inc. | 1 | 0 |
| Boston Scientific Corporation | 1 | 0 |
| Dart Medical Equipment | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2017 | K170815 | PSA Cable Boston Scientific Corporation | DTC |
| Apr 1, 2009 | K083674 | PK-141 PATIENT CABLE Biotronik, Inc. | DTC |
| Aug 30, 2001 | K011729 | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 Dni Nevada, Inc. | DTC |
| Oct 10, 2000 | K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER Pace Medical | DTC |
| Nov 8, 1996 | K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 North American Technical Services Corp. | DTC |
| Jun 19, 1991 | K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 Bio-Tek Instruments, Inc. | DTC |
| May 7, 1991 | K910595 | MODEL 5311B A-V PACING SYSTEM ANALYZER Medtronic Vascular | DTC |
| Mar 19, 1991 | K910223 | CPI MODEL 2215/SEAMED MODEL 3400 Seamed Corp. | DTC |
| May 9, 1990 | K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE Biotronik, GmbH & Co. | DTC |
| Dec 13, 1989 | K896632 | MEDTRONIC MODEL 5401B TEST CABLE Medtronic Vascular | DTC |
| Jan 10, 1989 | K884331 | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER Medtronic Vascular | DTC |
| Oct 6, 1988 | K882327 | PACER SENSING ANALYZER (PSA 100) Oscor Medical Corp. | DTC |
| Aug 19, 1986 | K860462 | SEAMED MODEL 3000 Seamed Corp. | DTC |
| Jul 19, 1985 | K851900 | SEA MED DDD PACING SYSTEM ANALYZER Seamed Corp. | DTC |
| Jul 16, 1985 | K850077 | MEDTRONIC 5311 PACING SYSTEM ANALYZER Medtronic Vascular | DTC |
| May 1, 1985 | K844969 | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) Cordis Corp. | DTC |
| Sep 4, 1984 | K831697 | TELECTRONICS MODEL 2401 Seamed Corp. | DTC |
| Jun 17, 1982 | K812262 | MEDTRONIC A-V PACING SYSTEM ANALYZER Medtronic Vascular | DTC |
| Apr 14, 1981 | K810604 | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 Telectronics, Inc. | DTC |
| Mar 25, 1980 | K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR Ela Medical, Inc. | DTC |
| Mar 12, 1980 | K800286 | CRITERION II PACING SYSTEM MONITORS Dart Medical Equipment | DTC |
| Jan 31, 1980 | K791975 | PACING SYSTEM ANALYZER PSA SCE-22 Ela Medical, Inc. | DTC |
| Dec 27, 1979 | K792074 | MODEL 674 PACER ANALYZER Del Mar Avionics | DTC |
| Sep 21, 1979 | K791762 | SELF CHECK Instromedix, Inc. | DTC |
| Aug 31, 1978 | K781349 | PACER-TRACER PULSE WIDTH Instromedix, Inc. | DTC |
| Aug 23, 1978 | K781144 | ANALYZER, PACER SYSTEM, PSA-5 Edwards Pacemaker Systems | DTC |
| Jun 30, 1978 | K780717 | EXTERNAL TEST PULSE GENERATOR Vitatron Medical BV | DTC |
| Nov 2, 1977 | K771922 | MINICLINIC TM Instromedix, Inc. | DTC |
| Jun 14, 1977 | K770865 | MONITOR, PACEMAKER Adcor Electronics, Inc. | DTC |
| Jul 20, 1976 | K760013 | PACER SYSTEMS ANALYZER (CORDIS) Cordis Corp. | DTC |
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