Type YC Endocardial Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810491 ↗

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 purpose of the Type YC Endocardial Lead, and how does it function in a patient’s body?

  The Type YC Endocardial Lead is designed as a permanent pacemaker electrode to establish an electrical connection between a pacemaker or defibrillator and the heart’s internal chambers. It facilitates cardiac rhythm regulation by transmitting electrical impulses, ensuring proper heart function in patients requiring pacing support.

• Is the Type YC Endocardial Lead intended for single-use or reusable applications, and what does this mean for clinical workflows?

  The Type YC Endocardial Lead is explicitly supplied as a reusable medical device. This means it can be sterilized and used multiple times across different patients, which may impact clinical workflows by requiring proper cleaning, sterilization, and inventory management to ensure safe and compliant reuse.

• What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?

  The Type YC Endocardial Lead received FDA clearance through a Traditional 510(k) pathway, classified under Class III and filed under product code DTB. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its intended use in cardiovascular procedures.

• Are there any specific storage requirements or considerations mentioned for this device?

  The provided data does not include explicit storage instructions for the Type YC Endocardial Lead. However, as a reusable medical device, proper handling, cleaning, and sterilization protocols must be followed to maintain functionality and ensure patient safety. Always refer to manufacturer guidelines for detailed storage recommendations.