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Temporary Pacemaker Ground Wire

by Scholten Surgical Instruments, Inc.

510(k) K852119

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852119 Date15 Sep 1985ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DTB
Device class
Class III
Regulation
21 CFR Part 870.3680
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Similar devices

Other devices filed under FDA product code DTB (Permanent Pacemaker Electrode).

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