C-L0L Cardiac Pacemaker

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

510(k) Number

K770559 ↗

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 C-L0L Cardiac Pacemaker designed to treat, and how does it work?

  The C-L0L Cardiac Pacemaker is designed to regulate abnormal heart rhythms, specifically for patients with bradycardia or conduction disorders that require chronic cardiac pacing. It works by delivering controlled electrical impulses to the heart muscle, helping to maintain a proper heart rate and rhythm when the heart’s natural electrical system is not functioning correctly.

• Is the C-L0L Cardiac Pacemaker intended for reuse, or is it meant to be implanted permanently as a single-use device?

  The C-L0L Cardiac Pacemaker is explicitly intended for single-use within the body after implantation. Once placed subcutaneously, it is not designed to be removed or reused, aligning with its classification as an implantable device.

• What regulatory pathway was followed for FDA clearance of the C-L0L Cardiac Pacemaker, and what does that mean for its use?

  The C-L0L Cardiac Pacemaker received FDA clearance through a 510(k) pathway, specifically under the Traditional clearance type, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it meets the same performance standards as a previously approved device and is safe and effective for its intended use in regulating abnormal heart rhythms.

• How is the C-L0L Cardiac Pacemaker supplied, and are there any special handling or storage requirements mentioned?

  The data does not specify packaging details or special handling instructions, but as an implantable device, it is likely supplied sterile and ready for surgical implantation. Since it is intended for single-use, proper sterile storage (e.g., in a sealed, sterile pouch) before use is implied, though exact storage conditions are not documented in the provided information.