Type FH Endocardial Lead

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

510(k) Number

K810494 ↗

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 Type FH Endocardial Lead used for in clinical practice?

  The Type FH Endocardial Lead is designed for permanent endocardial pacing, meaning it is implanted inside the heart to deliver electrical stimuli that regulate heart rhythm and manage arrhythmias. It is specifically intended for use with pacemaker systems to ensure proper cardiac contractions when the heart’s natural electrical system is impaired.

• Is this lead single-use or reusable, and how should it be handled?

  This lead is sterile and intended for single-use only. It must be handled under sterile conditions to prevent contamination before implantation. Since it is not designed for reuse, any unused portion must be discarded according to sterile medical device protocols.

• What regulatory pathway does this device follow, and how does that affect its use?

  The Type FH Endocardial Lead is cleared under the FDA 510(k) pathway (K810494) as a Class III device, classified under product code DTB (Cardiovascular Specialty). This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for endocardial pacing applications. Clinicians should confirm compliance with the manufacturer’s instructions and sterile handling guidelines.

• Are there multiple sizes or models of this lead, and how would I identify the correct one?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232), which likely correspond to different batch or lot identifiers rather than distinct sizes or models. However, the core design remains consistent for endocardial pacing. To ensure compatibility, verify the specific FEI or lot number against your pacemaker system’s requirements, as variations may exist in lead dimensions or connector types. Always consult the manufacturer’s documentation for precise sizing.