L-501 Cardiac Pacemaker

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

510(k) Number

K771992 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Endo-Lok L-40 Endocardial Pacing Electrode

  Class III

  FDA 510(k) K760714 Active Cleared 14 Dec 1976

• Coratomic #VX5-105 & VX5-205 Pulse Gen.

  Class III

  FDA 510(k) K822791 Active Cleared 15 Dec 1982

• L-15T Endocardial Pacing Electrode

  Not classified

  FDA 510(k) K802689 Active Cleared 28 Oct 1980

• Ovalith-920

  Class III

  FDA 510(k) K810808 Active Cleared 15 May 1981

• Endocardial Pacing Electrode

  Class III

  FDA 510(k) K772309 Active Cleared 6 Feb 1978

• OVALITH-300 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K790446 Active Cleared 30 Jul 1979

See all devices from Coratomic, Inc. →

• What types of heart conditions is the L-501 Cardiac Pacemaker designed to address, and how does it work?

  The L-501 Cardiac Pacemaker is specifically designed to manage bradycardia (slow heart rate) and other conduction disorders, where the heart’s natural electrical system fails to maintain proper rhythm. It works by delivering controlled electrical impulses to the heart muscle, artificially pacing it to ensure consistent contractions and maintain normal cardiac function.

• Is the L-501 Cardiac Pacemaker intended for single-use or can it be reused after implantation?

  The L-501 Cardiac Pacemaker is not a single-use device—it is designed for permanent implantation and is intended to remain in the patient’s body long-term. Unlike disposable devices, it is reusable in the sense that it is meant to function continuously once implanted, though it may require battery replacement or adjustments over time.

• How is the L-501 Cardiac Pacemaker supplied, and what should clinicians consider during storage?

  The L-501 is supplied as a sterile, implantable system (though no specific sterility assurances are noted in the data). Since it is intended for surgical implantation, clinicians should store it in a clean, controlled environment to prevent contamination before use. The device’s reusable nature means it should also be handled with sterile techniques during any post-implantation adjustments or battery replacements.

• What regulatory pathway was followed for the FDA clearance of the L-501 Cardiac Pacemaker, and how does that affect its use?

  The L-501 Cardiac Pacemaker received FDA 510(k) clearance (K771992) through a traditional review process, with a determination of substantial equivalence to a predicate device. This means the device was evaluated against existing pacemakers to ensure it meets safety and effectiveness standards. Clinicians can rely on this clearance to confirm the device adheres to cardiovascular medical specialty regulations (870.3610) and is suitable for managing bradycardia or conduction disorders.