Ovalith 10BP

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

510(k) Number

K781377 ↗

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 Ovalith 10BP used for in clinical practice?

  The Ovalith 10BP is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. It delivers electrical impulses to stimulate the heart when the body’s natural pacing system is insufficient, ensuring steady cardiac output for patients who require chronic cardiac support.

• Is the Ovalith 10BP intended for single-use or can it be reused?

  The Ovalith 10BP is explicitly supplied as a single-use device. It is intended for sterile surgical implantation by qualified medical professionals and should not be reused after one procedure to maintain patient safety and sterility.

• How should the Ovalith 10BP be stored and handled?

  The Ovalith 10BP must be stored and handled according to sterile medical device protocols. Since it is implantable, it is provided in a sterile packaging to ensure it remains uncontaminated before use in the operating room.

• What regulatory pathway was followed for the Ovalith 10BP’s approval?

  The Ovalith 10BP received FDA clearance through a 510(k) submission (K781377) under the Traditional clearance type. It was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and classified as a Class III device (DXY), adhering to strict regulatory standards for cardiovascular implants.