Biotronik DYC Unipolar PE-60/4-DYC

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K833101 ↗

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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• What is the primary clinical purpose of the Biotronik DYC Unipolar PE-60/4-DYC device, and how does it function in the body?

  The Biotronik DYC Unipolar PE-60/4-DYC is a permanent pacemaker electrode designed to deliver unipolar pacing stimulation within the cardiovascular system. It regulates heart rhythm by providing consistent electrical signals to the myocardium, which is essential for patients experiencing bradycardia (slow heart rate) or conduction disorders where the heart’s natural electrical system is impaired.

• Is this device intended for reuse, or is it meant for single-use only? How should it be stored before use?

  The Biotronik DYC Unipolar PE-60/4-DYC is explicitly intended for single-use implantation by qualified healthcare professionals. To maintain its sterility and integrity, it must be stored in a clean, dry environment prior to use, as specified in the manufacturer’s instructions.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  This device received FDA 510(k) clearance through a traditional pathway, classified as a Class III medical device under regulation 870.3680. The clearance was determined to be *substantially equivalent* to a predicate device, and the submission was reviewed by the Cardiovascular (CV) Advisory Committee.

• Are there any special considerations for MRI compatibility with this pacemaker lead?

  Yes, the Biotronik DYC Unipolar PE-60/4-DYC is designed with MRI safety guidelines for pacemaker leads in mind. However, specific MRI protocols and restrictions should be followed as per the manufacturer’s instructions to ensure patient safety during imaging procedures.