L-12, L-21, and L-22 Electrodes

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

510(k) Number

K780569 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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. →

• Are these electrodes reusable or intended for single-use only, and how does that affect their storage requirements?

  The L-12, L-21, and L-22 electrodes are explicitly designed for single-use implantation only. Since they are sterile upon supply, they must be stored according to the manufacturer’s instructions to maintain sterility until use. Reusing these electrodes is not recommended, as it could compromise patient safety and regulatory compliance.

• What types of heart conditions are these electrodes intended to address, and how do they work?

  These electrodes are permanent pacemaker electrodes used to facilitate electrical stimulation of cardiac tissue. They are specifically intended for patients with bradycardia or conduction disorders, helping regulate heart rhythm by acting as a conductive interface between the pacemaker pulse generator and the heart. They are not meant for acute or temporary pacing but rather long-term rhythm management.

• How do I identify the correct electrode model (L-12, L-21, or L-22) for my patient’s procedure?

  Each model (L-12, L-21, L-22) is uniquely identified by its reference code as specified by Coratomic, Inc. The selection should be based on the manufacturer’s guidelines, which align with the specific anatomical or clinical requirements of the patient’s cardiovascular procedure. Always verify the correct model against the procedural plan and electrode documentation.

• What regulatory pathway was followed for these electrodes, and what does that mean for their use?

  The L-12, L-21, and L-22 electrodes were cleared through the FDA 510(k) process under the classification of permanent pacemaker electrodes, with a decision code of SESE (Substantially Equivalent). This means they were determined to have the same intended use and technological characteristics as a legally marketed predicate device, ensuring compliance with 21 CFR 870.3680. Their clearance does not imply any specific clinical indication beyond what is stated in the description.