Ovalith 920BP

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

Full name

Coratomic Model Ovalith 920BP

510(k) Number

K821014 ↗

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 920BP used for in clinical practice?

  The Ovalith 920BP is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients who require chronic pacing support to maintain consistent heart contractions and proper cardiac function, particularly those with conditions causing slow heart rates or irregular rhythms.

• Is the Ovalith 920BP a single-use or reusable device, and how is it supplied?

  The Ovalith 920BP is a reusable, implantable device, meaning it is intended for long-term use within a patient after surgical implantation. It is not a disposable item and must be handled in sterile conditions during procedures, as required for all implantable medical devices.

• What regulatory pathway was followed for FDA clearance of the Ovalith 920BP?

  The Ovalith 920BP received FDA 510(k) clearance (K821014) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It was reviewed by the Cardiovascular (CV) Advisory Committee and classified under product code DXY, reflecting its classification as a Class III Implantable Pacemaker Pulse-Generator under FDA regulation 870.3610.

• Are there multiple models or sizes available for the Ovalith 920BP?

  The provided data does not specify multiple models or sizes for the Ovalith 920BP, but it is listed under OpenFDA registration numbers (e.g., 2017865, 3005334138) which may indicate variations or lot-specific identifiers. For precise sizing or model variations, consult the manufacturer’s technical documentation or contact Coratomic, Inc. directly.