Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3690](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3690) → DTG — Magnet, Test, Pacemaker

# DTG · Magnet, Test, Pacemaker

_Cardiovascular · 21 CFR 870.3690 · Class 1_

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

## Overview

- **Product Code:** DTG
- **Device Name:** Magnet, Test, Pacemaker
- **Regulation:** [21 CFR 870.3690](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3690)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092364](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTG/K092364.md) | MODEL 220 PATIENT MAGNET | Cyberonics, Inc. | Nov 3, 2009 | SESE |
| [K960849](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTG/K960849.md) | MAGNO ALARM | Cardiac Assist Devices, Inc. | Mar 26, 1997 | SESE |
| [K895110](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTG/K895110.md) | MAESTRO PACEMAKER TEST MAGNET | Cardiac Control Systems, Inc. | Sep 26, 1989 | SESE |
| [K831926](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTG/K831926.md) | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oscor, Inc. | Mar 12, 1984 | SESE |
| [K813153](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTG/K813153.md) | TEST MAGNET | Pacesetter Systems | Dec 2, 1981 | SESE |

## Top Applicants

- Cardiac Assist Devices, Inc. — 1 clearance
- Cardiac Control Systems, Inc. — 1 clearance
- Cyberonics, Inc. — 1 clearance
- Oscor, Inc. — 1 clearance
- Pacesetter Systems — 1 clearance

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

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