NHW · Electrode, Pacing And Cardioversion, Temporary, Epicardial
Cardiovascular · 21 CFR 870.3680 · Class 2
Overview
| Product Code | NHW |
|---|---|
| Device Name | Electrode, Pacing And Cardioversion, Temporary, Epicardial |
| Regulation | 21 CFR 870.3680 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
Classification Rationale
Temporary pacemaker electrode: Class II (performance standards). Permanent pacemaker electrode: Class III (premarket approval).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K024071 | GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM | Guidant Corporation, Cardiac Surgery | Feb 14, 2003 | SESE |
| K020701 | SYNCRUS INTERNAL CARDIOVERSION SYSTEM | Guidant Corporation, Cardiac Surgery | May 24, 2002 | SESE |
Top Applicants
- Guidant Corporation, Cardiac Surgery — 2 clearances
