OVALITH-300 Implantable Pacemaker Pulse-Generator

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

Full name

Ovalith-300

510(k) Number

K790446 ↗

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

• C-L0L Cardiac Pacemaker

  Class III

  FDA 510(k) K770559 Active Cleared 28 Mar 1977

See all devices from Coratomic, Inc. →

• Is the Ovalith-300 designed for single-use or can it be reused after implantation?

  The Ovalith-300 is explicitly described as a reusable, implantable component. Since it is intended for long-term cardiac pacing and classified under FDA regulation 870.3610 for implantable electronics, it is not a single-use device. Reuse is permitted as part of its design and regulatory pathway, though proper sterilization and handling protocols must be followed per manufacturer guidelines.

• What types of heart conditions is the Ovalith-300 approved to treat, and how does it work?

  The Ovalith-300 is intended for patients with bradycardia or conduction disorders requiring chronic cardiac pacing. It works by delivering electrical impulses to the heart muscle when the heart’s natural contractions are insufficient, thereby regulating heart rhythm. This is a standard function of implantable pacemaker pulse-generators, and the device’s approval reflects its role in managing these specific cardiac conditions.

• How is the Ovalith-300 regulated by the FDA, and what does its classification mean for clinicians?

  The Ovalith-300 is a Class III medical device regulated under FDA 510(k) clearance (K790446) and falls under regulation number 870.3610. This classification means it is subject to strict manufacturing and sterility standards, as it is an implantable electronic device. The device was deemed substantially equivalent to prior generations, ensuring it meets existing safety and performance criteria for pacemaker pulse-generators.

• Does the Ovalith-300 come with any specific storage requirements, and is it sterile upon receipt?

  The provided data does not explicitly detail storage requirements or sterility status for the Ovalith-300. However, as an implantable device regulated under FDA standards for electronics, it must adhere to strict manufacturing protocols to ensure sterility before use. Clinicians should follow the manufacturer’s instructions for handling, storage, and preparation to maintain device integrity and patient safety.