DNR Unipolar Permanent Pacemaker Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Dnr Unipolar

510(k) Number

K853568 ↗

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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  FDA 510(k) K833098 Active Cleared 19 Oct 1983

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  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

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  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

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• Pulse Generator

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  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

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  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What is the DNR Unipolar device used for in clinical practice?

  The DNR Unipolar is a permanent pacemaker electrode designed to be implanted in the heart to deliver electrical pacing therapy. It works with a pacemaker system to stimulate the myocardium, helping regulate abnormal heart rhythms like bradycardia or conduction disorders by ensuring proper cardiac function.

• Is the DNR Unipolar electrode intended for single-use or can it be reused?

  The DNR Unipolar electrode is explicitly intended for single-use implantation. It is supplied sterile and must be handled under aseptic conditions, following standard surgical protocols for pacemaker lead placement to maintain sterility and safety.

• How many model numbers are available for the DNR Unipolar electrode, and how can I identify them?

  The DNR Unipolar electrode comes in multiple model numbers, which are listed in the FDA’s OpenFDA database under the registration numbers (e.g., 2017865, 3002618605, etc.). These identifiers help distinguish between different variants, though exact specifications like length or tip design would require cross-referencing with Biotronik’s documentation.

• What storage or handling precautions should be taken with the DNR Unipolar electrode before implantation?

  The electrode must be stored and handled under aseptic conditions to preserve sterility, as it is supplied sterile for single-use. Adherence to standard surgical protocols for pacemaker lead placement is required to prevent contamination and ensure safe implantation.

• What regulatory pathway was followed for FDA clearance of the DNR Unipolar electrode?

  The DNR Unipolar electrode received FDA 510(k) clearance through a *Traditional* review process, determined to be *Substantially Equivalent* to a predicate device. The clearance was granted under the *Cardiovascular* advisory committee (CV) and falls under product code *DTB*, with classification as a Class III device (870.3680).