Skip to content

TME Temporary Myocardial Electrode

by Osypka AG 510(k)

Active United States

510(k) K232261

Overview

The TME Temporary Myocardial Electrode is a temporary pacing lead designed for myocardial stimulation. It delivers electrical impulses to the heart muscle, facilitating temporary cardiac pacing to manage postoperative arrhythmias following cardiac surgery. The device is classified as a Class II electrode and is intended for direct myocardial contact, ensuring effective pacing support during recovery periods.

This electrode is supplied as a sterile, single-use device and is intended for surgical or transvenous application. It consists of flexible insulated electrical conductors connected to an external pacemaker pulse generator, with the other end applied to the atrium or ventricle. The device is regulated under 21 CFR 870.3680 and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Storage and handling must adhere to sterile medical device protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232261 Date26 Apr 2024ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
LDF
Regulation
21 CFR Part 870.3680
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Osypka AG

See all devices from Osypka AG →

Questions

  • What is the TME Temporary Myocardial Electrode used for?

    The TME Temporary Myocardial Electrode is designed for myocardial stimulation to provide temporary cardiac pacing. It is specifically intended for managing postoperative arrhythmias following cardiac surgery by delivering electrical impulses directly to the heart muscle, ensuring stable pacing support during recovery periods.

  • How is the TME Temporary Myocardial Electrode supplied and is it reusable?

    The TME Temporary Myocardial Electrode is supplied as a sterile, single-use device. It is not intended for reuse, and adherence to sterile medical device protocols is required during handling and application to maintain patient safety and device efficacy.

  • What types of applications does the TME Temporary Myocardial Electrode support?

    The device is intended for both surgical and transvenous application, allowing for direct myocardial contact with the atrium or ventricle. This flexibility ensures effective pacing support tailored to the patient’s postoperative needs.

  • How should the TME Temporary Myocardial Electrode be stored?

    The TME Temporary Myocardial Electrode must be stored according to sterile medical device protocols. This includes maintaining its sterile packaging until immediate use and ensuring it is kept in a clean, dry environment to preserve its integrity and functionality.

  • What regulatory pathway does the TME Temporary Myocardial Electrode follow?

    The TME Temporary Myocardial Electrode is regulated under 21 CFR 870.3680 and has received FDA 510(k) clearance as substantially equivalent to a predicate device. This classification ensures it meets stringent safety and performance standards for temporary myocardial stimulation.