DTF · Tools, Pacemaker Service
Cardiovascular · 21 CFR 870.3730 · Class 1
Overview
| Product Code | DTF |
|---|---|
| Device Name | Tools, Pacemaker Service |
| Regulation | 21 CFR 870.3730 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K875147 | TORQUE HEX WRENCH | Cardiac Pacemakers, Inc. | Jan 27, 1988 | SESE |
| K781179 | WRENCH, GEXAGON, DRIVER | Telectronics, Inc. | Jul 27, 1978 | SESE |
Top Applicants
- Cardiac Pacemakers, Inc. — 1 clearance
- Telectronics, Inc. — 1 clearance
