DTC · Analyzer, Pacemaker Generator Function
Cardiovascular · 21 CFR 870.3630 · Class 2
Overview
| Product Code | DTC |
|---|---|
| Device Name | Analyzer, Pacemaker Generator Function |
| Regulation | 21 CFR 870.3630 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170815 | PSA Cable | Boston Scientific Corporation | Jul 6, 2017 | SESE |
| K083674 | PK-141 PATIENT CABLE | Biotronik, Inc. | Apr 1, 2009 | SESE |
| K011729 | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 | Dni Nevada, Inc. | Aug 30, 2001 | SESE |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | Pace Medical | Oct 10, 2000 | SESE |
| K961582 | EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 | North American Technical Services Corp. | Nov 8, 1996 | SESE |
| K903966 | EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 | Bio-Tek Instruments, Inc. | Jun 19, 1991 | SESE |
| K910595 | MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | May 7, 1991 | SESE |
| K910223 | CPI MODEL 2215/SEAMED MODEL 3400 | Seamed Corp. | Mar 19, 1991 | SESE |
| K901332 | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE | Biotronik, GmbH & Co. | May 9, 1990 | SESE |
| K896632 | MEDTRONIC MODEL 5401B TEST CABLE | Medtronic Vascular | Dec 13, 1989 | SESE |
| K884331 | MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER | Medtronic Vascular | Jan 10, 1989 | SESE |
| K882327 | PACER SENSING ANALYZER (PSA 100) | Oscor Medical Corp. | Oct 6, 1988 | SESE |
| K860462 | SEAMED MODEL 3000 | Seamed Corp. | Aug 19, 1986 | SESE |
| K851900 | SEA MED DDD PACING SYSTEM ANALYZER | Seamed Corp. | Jul 19, 1985 | SESE |
| K850077 | MEDTRONIC 5311 PACING SYSTEM ANALYZER | Medtronic Vascular | Jul 16, 1985 | SESE |
| K844969 | CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) | Cordis Corp. | May 1, 1985 | SESE |
| K831697 | TELECTRONICS MODEL 2401 | Seamed Corp. | Sep 4, 1984 | SESE |
| K812262 | MEDTRONIC A-V PACING SYSTEM ANALYZER | Medtronic Vascular | Jun 17, 1982 | SESE |
| K810604 | ELECTRODE/PACER SYSTEM ANALYZER PMA 400 | Telectronics, Inc. | Apr 14, 1981 | SESE |
| K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR | Ela Medical, Inc. | Mar 25, 1980 | SESE |
Top Applicants
- Medtronic Vascular — 5 clearances
- Seamed Corp. — 4 clearances
- Instromedix, Inc. — 3 clearances
- Ela Medical, Inc. — 2 clearances
- Cordis Corp. — 2 clearances
