Biotronik Dy-Unipolar Pacemaker Lead Adaptor

No FDA recalls on record, checked 6 Oct 2026.

Full name

Biotronik Dy-Unipolar

510(k) Number

K841451 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

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

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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 primary purpose of the Biotronik Dy-Unipolar Pacemaker Lead Adaptor in cardiac rhythm management systems?

  The Biotronik Dy-Unipolar Pacemaker Lead Adaptor serves as a connector interface between pacemaker leads and the pulse generator. Its role is to ensure reliable electrical signal transmission, which is essential for maintaining proper pacing functionality during cardiac rhythm management procedures. This adaptor is specifically designed for use in clinical settings by healthcare professionals during pacemaker implantation or revision surgeries.

• Is the Biotronik Dy-Unipolar Pacemaker Lead Adaptor intended for single-use or reusable applications?

  The Biotronik Dy-Unipolar Pacemaker Lead Adaptor is explicitly supplied as a reusable device. This design choice allows for multiple uses in clinical settings, reducing waste and potentially lowering costs for healthcare providers while maintaining functionality for pacemaker systems.

• How is the regulatory status of this device determined, and what pathway was followed for FDA clearance?

  The Biotronik Dy-Unipolar Pacemaker Lead Adaptor received FDA clearance through the Traditional 510(k) pathway under the Cardiovascular (CV) Advisory Committee, with a decision classification of Substantially Equivalent (SESE). The product is categorized under product code DTD, confirming its classification as a Class II cardiovascular device. The clearance number is K841451, and the device was filed in 1984.

• What types of pacemaker leads is this adaptor compatible with, and how does it ensure proper functionality?

  While the exact compatibility with specific lead models isn’t detailed in the provided data, the adaptor is designed to facilitate electrical signal transmission between unipolar pacemaker leads and the pulse generator. Its role is critical in ensuring that pacing signals are accurately delivered to the heart during cardiac rhythm management, which is essential for devices used in bradycardia or other pacing-dependent conditions. The adaptor’s design ensures a secure and reliable connection to maintain proper pacing functionality.

• Are there any special handling or storage requirements mentioned for the Biotronik Dy-Unipolar Pacemaker Lead Adaptor?

  The provided data does not specify any special handling or storage requirements for the Biotronik Dy-Unipolar Pacemaker Lead Adaptor, such as sterility assurances or environmental conditions. However, since it is a reusable device used in sterile clinical procedures, it should be cleaned and maintained according to standard medical device reprocessing protocols to ensure safety and functionality. Always follow manufacturer guidelines for proper care and storage.