KRG · Programmer, Pacemaker
Cardiovascular · 21 CFR 870.3700 · Class 3
Overview
| Product Code | KRG |
|---|---|
| Device Name | Programmer, Pacemaker |
| Regulation | 21 CFR 870.3700 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | Intermedics, Inc. | Mar 15, 1995 | SESE |
| K884522 | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER | Teletronics, Inc. | Aug 25, 1989 | SESE |
| K880738 | MODEL 2331T PATIENT PROGRAMMER | Medtronic Vascular | Nov 17, 1988 | SESE |
| K882429 | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | Tpl-Cordis, Inc. | Jul 22, 1988 | SESE |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | Telectronics, Inc. | Dec 17, 1987 | SESE |
| K871986 | MODEL 5600B PROGRAMMER, PACEMAKER | Telectronics, Inc. | Jun 24, 1987 | SESE |
| K863046 | ULTRA SOFTWARE MODULE: MODEL 2016 | Cardiac Pacemakers, Inc. | Dec 5, 1986 | SESE |
| K863045 | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 | Cardiac Pacemakers, Inc. | Sep 29, 1986 | SESE |
| K860584 | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN | Cardiac Pacemakers, Inc. | Jun 6, 1986 | SESE |
| K860546 | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 | Pacesetter Systems | Apr 23, 1986 | SESE |
| K844484 | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | Vitatron Medical BV | Jul 24, 1985 | SESE |
| K844485 | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | Vitatron Medical BV | Apr 19, 1985 | SESE |
| K844483 | TP 1 | Vitatron Medical BV | Apr 19, 1985 | SESE |
| K842364 | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR | Cardiac Pacemakers, Inc. | Sep 24, 1984 | SESE |
| K820230 | PACEMAKER PROGRAMMER 2030 | Cardiac Pacemakers, Inc. | Mar 15, 1982 | SESE |
| K812761 | FLOW-DIRECTED BALLOON THERMODILUTION | Nova Medical Specialties | Nov 2, 1981 | SESE |
| K812813 | INTERMEDICS PROGRAMMER, MODEL 522-03 | Intermedics, Inc. | Oct 27, 1981 | SESE |
| K811217 | PACEMAKER PROGRAMMER #2010 | Cardiac Pacemakers, Inc. | Jul 20, 1981 | SESE |
| K810552 | CORDIS PACEMAKER PROGRAMMERS 255A & 256A | Cordis Corp. | Mar 20, 1981 | SESE |
| K800376 | EPR-200 PROGRAMMER MODEL 010 | Biotronik Sales, Inc. | Apr 21, 1980 | SESE |
Top Applicants
- Cardiac Pacemakers, Inc. — 7 clearances
- Intermedics, Inc. — 4 clearances
- Cordis Corp. — 3 clearances
- Vitatron Medical BV — 3 clearances
- Telectronics, Inc. — 2 clearances
