Biotronik Permanent Pacemaker Electrode

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863480 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

  Class III

  FDA 510(k) K833098 Active Cleared 19 Oct 1983

• Biotronik D2K Unipolar PE-60/4

  Class III

  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

  Class III

  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Neos-M VS-1 Pulse Generator

  Class III

  FDA 510(k) K863879 Active Cleared 10 Dec 1986

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• What clinical conditions is this pacemaker electrode designed to address, and how does it work?

  This device is specifically intended for patients with bradycardia or heart block, where the heart’s natural electrical conduction system is impaired or insufficient. The Biotronik Permanent Pacemaker Electrode delivers controlled electrical impulses to the heart muscle, helping to restore and maintain a normal heart rate by compensating for the impaired conduction system.

• Is this electrode single-use or reusable, and how is it supplied?

  The Biotronik Permanent Pacemaker Electrode is supplied sterile and is intended for single-use only. It is designed for surgical implantation and should not be reused after one procedure to ensure patient safety and sterility.

• What regulatory pathway does this device follow, and what does that mean for its use?

  This device follows the FDA 510(k) clearance pathway under the product code DTB, classified as a Class III medical device. The clearance (K863480) confirms it meets FDA standards for cardiovascular applications, ensuring compliance with rigorous safety and performance requirements before clinical use.

• Are there multiple models available, and how do I determine compatibility with my pacemaker system?

  Yes, multiple model references are available for this electrode, each designed to ensure compatibility with various pacemaker systems. The listed FEI numbers (e.g., 3002618605, 1028232) correspond to specific electrode models, so you should verify the exact model number required for your pacemaker system before ordering.

• How should this electrode be stored before use, and what precautions should be taken?

  Since the electrode is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. Storage should follow manufacturer guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or integrity before opening.