Ovalith P-BP Bipolar Cardiac Pacemaker

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

510(k) Number

K800194 ↗

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 P-BP Bipolar Cardiac Pacemaker used for in clinical practice?

  The Ovalith P-BP Bipolar Cardiac Pacemaker is designed to regulate heart rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses to the heart. It is intended for surgical implantation by qualified healthcare professionals to support patients whose natural pacemaker function is compromised.

• Is the Ovalith P-BP Bipolar Cardiac Pacemaker intended for single-use or can it be reused?

  The Ovalith P-BP Bipolar Cardiac Pacemaker is supplied as a single-use implantable unit. This means it is intended for one-time surgical implantation and should not be reused after removal or sterilization.

• How should the Ovalith P-BP Bipolar Cardiac Pacemaker be stored and handled?

  Due to its classification as a sterile medical device, the Ovalith P-BP Bipolar Cardiac Pacemaker must be stored and handled according to sterile medical device protocols. This ensures proper preservation of sterility until surgical implantation by qualified healthcare professionals.

• What regulatory pathway was followed for the approval of this device?

  The Ovalith P-BP Bipolar Cardiac Pacemaker was cleared through the FDA’s 510(k) pathway, specifically under the product code DXY, and is classified as a Class III medical device. It was reviewed by the Cardiovascular (CV) Advisory Committee and granted clearance as substantially equivalent to a predicate device.

• What types of patients is this device intended for?

  This device is intended for patients with bradycardia or conduction disorders who require cardiac pacing. It is designed for surgical implantation by qualified healthcare professionals in sterile operating environments to provide electrical stimulation to the heart when its natural rhythm is insufficient.