Biotronik N Bipolar PEB-60/4-N

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833099 ↗

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

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• Is this pacemaker lead designed for reuse in multiple patients or is it intended for single-use only?

  The Biotronik N Bipolar PEB-60/4-N is explicitly intended for single-use implantation in cardiac procedures. This is confirmed by its classification as a sterile surgical device supplied ready for one-time use, per the provided regulatory data.

• What types of cardiac conditions is this lead approved to treat, and how does it work?

  This lead is intended for electrical stimulation of the heart to regulate rhythm in patients with bradycardia or conduction disorders. It delivers pacing impulses via a bipolar design, ensuring targeted stimulation to maintain proper cardiac function.

• How is this device supplied, and what should clinicians verify before use?

  The lead is supplied sterile for surgical use, meaning it is pre-packaged and ready for immediate implantation without additional sterilization. Clinicians should confirm the sterile packaging is intact and verify the single-use designation to avoid reuse, as per the manufacturer’s specifications.

• What regulatory pathway was used for FDA clearance, and when was it originally approved?

  The Biotronik N Bipolar PEB-60/4-N was cleared via the Traditional 510(k) pathway under the FDA’s Class 3 Cardiovascular device classification (product code DTB). It received its initial clearance on October 20, 1983, with a decision of *Substantially Equivalent* (SESE) to a predicate device.

• Are there any specific storage instructions mentioned for this device?

  The provided data does not include explicit storage instructions, but as a sterile, single-use medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s packaging guidelines to maintain sterility until use.