Type YR Endocardial Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810492 ↗

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 the Type YR Endocardial Lead designed for reuse in multiple patients or is it intended for single-use only?

  The Type YR Endocardial Lead is explicitly intended for single-use only after implantation. It is supplied sterile and must not be reused, as this could compromise sterility and patient safety. The manufacturer guidelines emphasize handling and storage protocols to preserve functionality and sterility for one-time use.

• What types of storage conditions are recommended to maintain the lead’s integrity before use?

  While the exact storage conditions aren’t detailed in the provided data, the lead is supplied sterile, so it must be stored in its original packaging to prevent contamination. The manufacturer’s guidelines (not listed here) would specify temperature and environmental controls, but generally, medical devices like this are stored in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

• How is this lead classified under FDA regulations, and what does that mean for its use in clinical settings?

  The Type YR Endocardial Lead is classified as a Class III medical device under FDA regulations, which means it is subject to strict premarket approval requirements. It has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a predicate device already on the market. This classification ensures rigorous evaluation of safety and effectiveness before clinical use, providing confidence in its reliability for endocardial pacing procedures.

• What are the key differences between this lead and other permanent pacemaker electrodes, based on the available data?

  The primary distinction highlighted in the data is its intended use for endocardial implantation, meaning it is designed to stimulate the inner lining of the heart chambers (endocardium). Unlike some other leads that may target different heart regions (e.g., epicardial or transvenous), this lead is specialized for direct contact with the endocardium. Additionally, its FDA 510(k) clearance and classification as a Class III device reflect its regulatory pathway, ensuring it meets stringent standards for safety and performance in cardiovascular pacing systems.