Biotronik D2K Unipolar PE-60/4

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833104 ↗

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

• 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

• Neos-M VS-1 Pulse Generator

  Class III

  FDA 510(k) K863879 Active Cleared 10 Dec 1986

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• What is the Biotronik D2K Unipolar PE-60/4 used for in clinical practice?

  The Biotronik D2K Unipolar PE-60/4 is designed specifically for unipolar pacing applications within cardiovascular interventions. It facilitates precise electrical conduction to support cardiac rhythm management, meaning it helps regulate heartbeats in patients who require pacemaker therapy.

• Is the Biotronik D2K Unipolar PE-60/4 intended for single-use or reusable in a clinical setting?

  This device is explicitly intended for single-use in clinical settings, requiring sterile handling to ensure patient safety and device efficacy. It is not designed for reuse.

• How is the Biotronik D2K Unipolar PE-60/4 supplied, and what should clinicians consider regarding sterility?

  The Biotronik D2K Unipolar PE-60/4 is supplied as a reusable component within a pacemaker system, though the electrode itself is single-use. Clinicians must adhere to standard medical device sterility protocols during handling to maintain its integrity and ensure safe use.

• What regulatory pathway does the Biotronik D2K Unipolar PE-60/4 follow, and what does this mean for its use?

  The device follows the FDA 510(k) clearance pathway, specifically under the product code DTB, and is classified as a Class III device. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in unipolar pacing applications.

• Are there any special storage requirements for the Biotronik D2K Unipolar PE-60/4 beyond standard medical device protocols?

  The provided data does not specify any additional storage requirements beyond standard medical device protocols. Clinicians should follow general guidelines for handling and storing cardiovascular devices to maintain their functionality and sterility.