Endocardial Pacing Electrode

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

510(k) Number

K772309 ↗

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

• OVALITH-300 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K790446 Active Cleared 30 Jul 1979

• C-L0L Cardiac Pacemaker

  Class III

  FDA 510(k) K770559 Active Cleared 28 Mar 1977

See all devices from Coratomic, Inc. →

• What is the Endocardial Pacing Electrode used for in clinical practice?

  The Endocardial Pacing Electrode is designed for transvenous placement within the heart to deliver electrical stimulation for cardiac pacing. It helps manage bradycardia or conduction disorders by ensuring synchronized contractions of the heart chambers through precise pacing impulses delivered via its electrode tip positioned in the endocardium.

• Is this device intended for reuse or single-use, and how should it be handled?

  The Endocardial Pacing Electrode is intended for single-use implantation only and is supplied sterile. Due to its sterile packaging and single-use designation, it requires proper sterile handling and storage to maintain integrity before use, adhering to standard medical device protocols.

• What regulatory pathway was followed for FDA clearance of this device?

  This device received FDA 510(k) clearance under classification III (DTB product code) through a traditional review process by the Cardiovascular (CV) Advisory Committee. The decision was based on a determination of substantial equivalence (SESE) to a predicate device, as filed in 1977 and cleared in 1978.

• Are there multiple model references available for this device?

  Yes, the Endocardial Pacing Electrode is available in multiple model references, as indicated by the listed FEI numbers (e.g., 3002618605, 2183787, etc.). These variations likely cater to different patient anatomies or clinical needs, though exact specifications would require consulting the manufacturer’s documentation.

• How should this device be stored before use?

  Since the device is supplied sterile and intended for single-use, it must be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and functionality until implantation, following standard medical device storage guidelines.