# Temporary Pacemaker Ground Wire

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb>
- Manufacturer: [Scholten Surgical Instruments, Inc.](https://devicerts.com/manufacturers/scholten-surgical-instruments-inc) (United States)
- Name in the registry: TEMPORARY PACEMAKER GROUND WIRE
- Device class: Class III (US FDA)
- FDA product code: DTB

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Temporary Pacemaker Ground Wire is a flexible insulated electrical conductor designed to connect an external temporary pacemaker pulse generator to the patient’s heart. It facilitates temporary cardiac pacing to manage bradycardia during surgical or diagnostic procedures, ensuring stable heart rhythm when endogenous conduction is compromised.

This device is intended for single-use in hospital operating rooms, electrophysiology labs, or cardiac catheterization suites. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance (K852119) under the classification of Class III (DTB). No MRI safety or reusable specifications are noted in the regulatory data.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K852119 · decision 1985-09-15 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K852119 [FDA 510(k)]
- FDA product code: DTB [FDA 510(k)]

## Classification

- Device class: Class III [FDA 510(k)]
- Regulation: 21 CFR Part 870.3680 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Temporary Pacemaker Ground Wire, Scholten Surgical Instruments, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/temporary-pacemaker-ground-wire-dtb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.