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

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

510(k) Number

K822791 ↗

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

• 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

• C-L0L Cardiac Pacemaker

  Class III

  FDA 510(k) K770559 Active Cleared 28 Mar 1977

See all devices from Coratomic, Inc. →

• What is the primary purpose of the CORATOMIC #VX5-105 & VX5-205 Pulse Generator, and which patients would benefit from it?

  The CORATOMIC #VX5-105 & VX5-205 Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients with bradycardia or conduction disorders requiring artificial pacing. It ensures consistent and reliable cardiac function, making it suitable for individuals whose natural heart rate or electrical signals are insufficient to maintain proper heart function.

• Are the CORATOMIC #VX5-105 and VX5-205 devices intended for reuse, or are they single-use implants?

  The CORATOMIC #VX5-105 and VX5-205 Pulse Generators are explicitly intended for single-use implantation after opening. They are supplied sterile, and adherence to sterile implantable device protocols is required to maintain integrity before surgical use, ensuring patient safety and device efficacy.

• How should the CORATOMIC #VX5-105 & VX5-205 Pulse Generator be stored before implantation, and why?

  The devices must be stored and handled according to sterile implantable device protocols to preserve their integrity. Since they are supplied sterile and intended for single-use, improper storage could compromise sterility, risking infection or device failure during implantation. Always follow manufacturer guidelines for packaging and environmental conditions.

• What regulatory pathway was followed for FDA clearance of the CORATOMIC #VX5-105 & VX5-205 Pulse Generator, and what does this mean for its use?

  The CORATOMIC #VX5-105 & VX5-205 Pulse Generator received FDA 510(k) clearance under the Cardiovascular advisory committee, with a decision of *Substantially Equivalent* (SESE). This means the device was determined to be at least as safe and effective as a legally marketed predicate device, allowing it to be marketed in the U.S. for its intended use in regulating cardiac rhythm via artificial pacing.

• What are the key differences between the VX5-105 and VX5-205 models, and how might a clinician choose between them?

  While the provided data does not specify technical differences between the VX5-105 and VX5-205 models (such as pacing capabilities or battery life), both are classified as Implantable Pacemaker Pulse-Generators under the same regulatory framework (870.3610). Selection would depend on clinical assessment, patient needs, and compatibility with the implanted leads or pacing requirements. Always refer to the manufacturer’s technical documentation for model-specific details.