510(k) K170815
- Device
- PSA Cable
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K170815
- Product code
- DTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-06
- Date received
- 2017-03-17
- Regulation
- 870.3630
- Classification name
- Analyzer, Pacemaker Generator Function
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Melissa Klamerus
- Address
- 4100 Hamline Ave. N St Paul MN US 55112 55112
FDA Registration Numbers#
- 2436826
- 3012260771
- 2124215
- 9610139
- 2182208
- 1028232
Source Documents#
Other 510(k) Records For Product Code DTC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
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