OVALITH-920

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

Full name

Coratomic Model Ovalith-920

510(k) Number

K810808 ↗

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) K821033 Active Cleared 28 May 1982

• 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 is the primary purpose of the Ovalith-920 pacemaker, and how does it function in the body?

  The Ovalith-920 is designed as an implantable pacemaker pulse-generator to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is intended for patients who require chronic cardiac pacing support, ensuring consistent heartbeats when the natural pacemaker fails or is insufficient.

• Is the Ovalith-920 meant for single-use or can it be reused after implantation?

  The Ovalith-920 is explicitly supplied sterile and intended for single-use implantation only. It must be implanted by qualified healthcare professionals in a clinical setting, following sterile medical device protocols to ensure patient safety.

• How is the Ovalith-920 regulated, and what does its FDA clearance status indicate?

  The Ovalith-920 is regulated under FDA 510(k) clearance (K810808) and classified as a Class III device, which means it is considered high-risk and life-sustaining. Its clearance status indicates it is substantially equivalent to a predicate device, meaning it meets the same performance standards as an already-approved pacemaker.

• What storage and handling precautions should be taken with the Ovalith-920?

  Since the Ovalith-920 is supplied sterile, it must be stored and handled according to sterile medical device protocols to maintain its integrity before implantation. Improper storage could compromise sterility, so follow manufacturer guidelines for packaging and environmental conditions.

• What types of healthcare settings or specialties would typically use the Ovalith-920?

  The Ovalith-920 is intended for use in cardiovascular specialties, such as electrophysiology or cardiology clinics, where qualified professionals perform implantable pacemaker procedures. Its design aligns with clinical settings equipped to handle high-risk, life-sustaining cardiac devices.