DRO · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Cardiovascular · 21 CFR 870.5550 · Class 2
Overview
| Product Code | DRO |
|---|---|
| Device Name | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Regulation | 21 CFR 870.5550 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.
Classification Rationale
Class II. The special controls for this device are:
Special Controls
*Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Katecho, Inc. | Oct 12, 2001 | SESE |
| K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | The Ludlow Company LP | Oct 12, 2001 | SESE |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Medical Data Electronics | Mar 28, 2000 | SESE |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Tz Medical, Inc. | Sep 15, 1999 | SESE |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Tz Medical, Inc. | Sep 15, 1999 | SESE |
| K974034 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | Mar 2, 1998 | SESE |
| K962547 | CARDIOSERV P | Marquette Electronics, Inc. | Mar 6, 1997 | SESE |
| K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | Marquette Electronics, Inc. | Feb 28, 1997 | SESE |
| K961138 | ESORT II + 400 SERIES MONITOR | Medical Data Electronics | Dec 10, 1996 | SESE |
| K951593 | LIFEPAK 11 | Physio-Control Corp. | Dec 29, 1995 | SESE |
| K950856 | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 | Zoll Medical Corp | Dec 29, 1995 | SESE |
| K950483 | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR | Hewlett-Packard Co. | May 22, 1995 | SESE |
| K926175 | K-DEFIB/PACE CARBON ELECTRODE | Katecho, Inc. | Apr 15, 1993 | SESE |
| K915757 | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS | Hewlett-Packard Co. | Jul 30, 1992 | SESE |
| K915328 | GEL-TAC | Katecho, Inc. | Jun 29, 1992 | SESE |
| K914955 | K-DEFIB/PACE ELECTRODE | Katecho, Inc. | May 14, 1992 | SESE |
| K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | Physio-Control Corp. | Sep 11, 1991 | SESE |
| K911956 | ZOLL PD-1400 PACER/DEFIBRILLATOR | Zmi Corp. | Jul 31, 1991 | SESE |
| K910661 | MODEL 205 SHOCK-TRODE | Cardiotronics, Inc. | May 2, 1991 | SESE |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Keller Medical Specialties Products, Inc. | Nov 16, 1990 | SESE |
Top Applicants
- Cardiac Resucitator Corp. — 13 clearances
- Physio-Control Corp. — 10 clearances
- Cardiotronics, Inc. — 9 clearances
- Medac, Inc. — 8 clearances
- Katecho, Inc. — 4 clearances
