Programmer, Pacemaker
This device is a pacemaker programmer, an external device used by clinicians to non-invasively communicate with and adjust the operational parameters of an implanted cardiac pacemaker, such as pacing rate, output, and sensitivity. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to the potential for the device to adversely affect the function of the life-sustaining implanted pacemaker. The product code is KRG, regulated under 21 CFR 870.3700 within the Cardiovascular specialty. No special flags such as implant or life-sustaining designations are recorded for this entry.
Basic Information
- Product Code
- KRG
- Device Class
- FDA class 3
- Regulation Number
- 870.3700
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 25 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | Mar 15, 1995 | Substantially Equivalent | INTERMEDICS, INC. |
| K884522 | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER | Aug 25, 1989 | Substantially Equivalent | TELETRONICS, INC. |
| K880738 | MODEL 2331T PATIENT PROGRAMMER | Nov 17, 1988 | Substantially Equivalent | MEDTRONIC VASCULAR |
| K882429 | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | Jul 22, 1988 | Substantially Equivalent | TPL-CORDIS, INC. |
| K864712 | MODEL 1740 PERSONAL POCKET PROGRAMMER | Dec 17, 1987 | Substantially Equivalent | TELECTRONICS, INC. |
| K871986 | MODEL 5600B PROGRAMMER, PACEMAKER | Jun 24, 1987 | Substantially Equivalent | TELECTRONICS, INC. |
| K863046 | ULTRA SOFTWARE MODULE: MODEL 2016 | Dec 05, 1986 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K863045 | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 | Sep 29, 1986 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K860584 | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN | Jun 06, 1986 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K860546 | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 | Apr 23, 1986 | Substantially Equivalent | PACESETTER SYSTEMS |
| K844484 | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | Jul 24, 1985 | Substantially Equivalent | VITATRON MEDICAL BV |
| K844485 | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | Apr 19, 1985 | Substantially Equivalent | VITATRON MEDICAL BV |
| K844483 | TP 1 | Apr 19, 1985 | Substantially Equivalent | VITATRON MEDICAL BV |
| K842364 | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR | Sep 24, 1984 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K820230 | PACEMAKER PROGRAMMER 2030 | Mar 15, 1982 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K812761 | FLOW-DIRECTED BALLOON THERMODILUTION | Nov 02, 1981 | Substantially Equivalent | NOVA MEDICAL SPECIALTIES |
| K812813 | INTERMEDICS PROGRAMMER, MODEL 522-03 | Oct 27, 1981 | Substantially Equivalent | INTERMEDICS, INC. |
| K811217 | PACEMAKER PROGRAMMER #2010 | Jul 20, 1981 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K810552 | CORDIS PACEMAKER PROGRAMMERS 255A & 256A | Mar 20, 1981 | Substantially Equivalent | CORDIS CORP. |
| K800376 | EPR-200 PROGRAMMER MODEL 010 | Apr 21, 1980 | Substantially Equivalent | BIOTRONIK SALES, INC. |
| K792580 | PACEMAKER PROGRAMMER | Dec 19, 1979 | Substantially Equivalent | CARDIAC PACEMAKERS, INC. |
| K791419 | OMNICOR PROGRAMMER MODEL 222C | Nov 27, 1979 | Substantially Equivalent | CORDIS CORP. |
| K790220 | PACEMAKER PROGRAMMER | Jul 31, 1979 | Substantially Equivalent | INTERMEDICS, INC. |
| K780175 | RATE PROGRAMMER MODEL 520 | Apr 21, 1978 | Substantially Equivalent | INTERMEDICS, INC. |
| K771855 | OMNICOR PROGRAMMER MODEL 222A | Oct 07, 1977 | Substantially Equivalent | CORDIS CORP. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.