OVALITH-920

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

Full name

Coratomic Model Ovalith-920

510(k) Number

K821033 ↗

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 is the primary purpose of the Ovalith-920 Implantable Pacemaker Pulse-Generator, and how does it function in the body?

  The Ovalith-920 is designed to regulate cardiac rhythm by delivering electrical impulses to the heart when the body’s natural conduction system fails. It acts as the power source and control unit for pacemaker systems, ensuring consistent pacing to maintain proper heart function in patients with bradycardia or conduction disorders. Essentially, it compensates for slow heartbeats by stimulating contractions at a controlled rate.

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

  The Ovalith-920 is supplied sterile for single-patient application only, meaning it is not intended for reuse. This ensures patient safety by preventing cross-contamination and maintaining sterility during implantation.

• How was the regulatory pathway for the Ovalith-920 determined, and what does this mean for its use?

  The Ovalith-920 was cleared through the FDA’s 510(k) process, specifically under a *Traditional* clearance route with a decision of *Substantially Equivalent* to a predicate device. This means the manufacturer demonstrated that it is as safe and effective as a previously approved pacemaker pulse-generator, allowing it to be marketed for its intended use in regulating cardiac rhythm without requiring a full pre-market approval.

• What storage or handling precautions should be taken with the Ovalith-920 before implantation?

  While the provided data does not specify detailed storage instructions, the device is supplied sterile for single-patient use. Standard sterile medical device handling practices should be followed, including keeping it in its original packaging until ready for use and avoiding contamination or exposure to moisture or extreme temperatures.