Lithicron II 0403 Implantable Pacemaker

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

510(k) Number

K791678 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lithicron Model 3-70C-B Pulse Generator

  Class III

  FDA 510(k) K771538 Active Cleared 22 Aug 1977

• Lithicron 0520 P-Synchroneous Pulse Gen.

  Class III

  FDA 510(k) K792609 Active Cleared 19 Nov 1980

• Lithicron Model 0401 Pacemaker

  Class III

  FDA 510(k) K791095 Active Cleared 10 Aug 1979

• Lithicron F Programmable Pulse Gen

  Class III

  FDA 510(k) K780430 Active Cleared 22 Dec 1978

• Quintrex 0516 Prog. Pulse Generator Sys

  Not classified

  FDA 510(k) K802224 Active Cleared 12 Sep 1980

• Pulse Generator, Litkicron Model 3-70H

  Class III

  FDA 510(k) K770507 Active Cleared 7 Apr 1977

See all devices from Medcor, Inc. →

• What is the Lithicron II 0403 Implantable Pacemaker used for in clinical practice?

  The Lithicron II 0403 Implantable Pacemaker is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails. It is specifically intended for patients with bradycardia or conduction disorders, helping maintain proper cardiac function by ensuring consistent, controlled heartbeats.

• Is the Lithicron II 0403 Implantable Pacemaker intended for single-use or can it be reused?

  The Lithicron II 0403 Implantable Pacemaker is supplied as a single-use device. Due to its sterile handling requirement before use, it is not designed for reuse, ensuring patient safety and compliance with medical device regulations.

• How is the Lithicron II 0403 Implantable Pacemaker regulated and what does its FDA clearance status mean?

  The Lithicron II 0403 Implantable Pacemaker holds an FDA 510(k) clearance (K791678) under the classification of an Implantable Pacemaker Pulse-Generator. This clearance indicates that the device was determined to be substantially equivalent to a predicate device already on the market, meeting regulatory standards for cardiovascular implantable electronics as outlined in 21 CFR 870.3610.

• What type of handling and storage precautions should be taken with the Lithicron II 0403 Implantable Pacemaker?

  The Lithicron II 0403 Implantable Pacemaker requires sterile handling prior to use, as it is intended for surgical implantation. Proper storage should maintain its sterility and integrity until implantation, following standard protocols for implantable medical devices to prevent contamination or damage.