Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3730](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3730) → DTF — Tools, Pacemaker Service

# DTF · Tools, Pacemaker Service

_Cardiovascular · 21 CFR 870.3730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTF

## Overview

- **Product Code:** DTF
- **Device Name:** Tools, Pacemaker Service
- **Regulation:** [21 CFR 870.3730](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3730)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTF/K875147.md) | TORQUE HEX WRENCH | Cardiac Pacemakers, Inc. | Jan 27, 1988 | SESE |
| [K781179](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTF/K781179.md) | WRENCH, GEXAGON, DRIVER | Telectronics, Inc. | Jul 27, 1978 | SESE |

## Top Applicants

- Cardiac Pacemakers, Inc. — 1 clearance
- Telectronics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTF](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTF)

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