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Model FF..D & FX..D Pacemaker Leads

by Dr. Ing. P. Osypka, GmbH 510(k)

Active United States

510(k) K823896

Overview

The Model FF..D & FX..D Pacemaker Leads are classified as Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system to stimulate the heart muscle. These leads deliver electrical impulses to regulate abnormal heart rhythms, ensuring proper cardiac function in patients with bradycardia or other conduction disorders.

These leads are intended for single-use implantation in clinical settings such as cardiac catheterization labs or operating rooms. Sterilized via ethylene oxide, they are supplied sterile and packaged for immediate use. Compliance with FDA 510(k) clearance (K823896) ensures adherence to regulatory standards for Class III medical devices. Multiple reference codes (e.g., 3002618605, 1028232) identify variants, with no MRI safety restrictions stated.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823896 Date30 Apr 1983ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • Are these pacemaker leads intended for reuse in patients, or are they designed for single-use only?

    These leads are explicitly designed for single-use implantation in clinical settings like cardiac catheterization labs or operating rooms. The packaging is sterile upon arrival, and the device is not labeled or intended for reuse, ensuring patient safety and compliance with sterile procedure protocols.

  • How are these pacemaker leads sterilized, and what does that mean for handling before use?

    The leads are sterilized using ethylene oxide (EtO), a common method for medical devices. This means they arrive pre-sterilized in sealed packaging, ready for immediate use. Proper handling includes maintaining sterility until implantation, such as avoiding contamination or exposure to non-sterile surfaces.

  • What sizes or models are available for these pacemaker leads, and how do I identify the correct variant for a patient?

    Multiple variants exist, each identified by unique OpenFDA registration numbers (e.g., 3002618605, 1028232, etc.). These correspond to different lead designs or specifications. The correct model should be selected based on clinical needs (e.g., electrode placement, pacing requirements) and confirmed with your supplier or manufacturer’s documentation, as no single