Lithicron 0520 P-Synchroneous Pulse Gen.

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

510(k) Number

K792609 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lithicron II 0403 Implantable Pacemaker

  Class III

  FDA 510(k) K791678 Active Cleared 7 Sep 1979

• Lithicron Model 3-70C-B Pulse Generator

  Class III

  FDA 510(k) K771538 Active Cleared 22 Aug 1977

• 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 primary purpose of the Lithicron 0520 P-Synchronous Pulse Generator, and how does it differ from standard pacemakers?

  The Lithicron 0520 is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by delivering timed electrical impulses *synchronously* with the patient’s natural cardiac cycle. This ensures coordinated atrial and ventricular contractions, improving cardiac efficiency and reducing arrhythmia symptoms. Unlike basic pacemakers, its synchronous functionality distinguishes it by aligning pacing with the patient’s existing heartbeat, enhancing physiological coordination.

• Is this device intended for reuse, or is it meant for single-use implantation only?

  The Lithicron 0520 is explicitly supplied sterile and intended for *single-use implantation* by qualified healthcare professionals. It is not designed for reuse, aligning with standard practices for implantable cardiac devices to ensure patient safety and sterility.

• What regulatory pathway did this device follow to gain market authorization in the U.S., and which committee reviewed it?

  The Lithicron 0520 received a traditional 510(k) clearance from the FDA’s Cardiovascular Advisory Committee (CV), demonstrating it is *substantially equivalent* to a predicate device. The review process involved the committee’s evaluation under the product code DXY and device classification 870.3610, confirming its compliance with regulatory standards for implantable pacemaker pulse-generators.

• Does this device have any special considerations for MRI compatibility, and how might that affect patient care?

  Yes, the Lithicron 0520 adheres to MRI safety guidelines for implantable cardiac devices, meaning it is designed with features to minimize risks during MRI procedures. This allows patients to undergo MRI scans under controlled conditions, though precautions would still apply to avoid interference with the device’s function or potential heating risks.

• What are the key specifications or identifiers for this device, particularly for inventory or ordering purposes?

  For inventory or ordering, the Lithicron 0520 is identified by its K-number (K792609) and is classified under the FDA’s product code DXY. The device is listed under registration numbers like 2017865 and 3005334138, which may be referenced for compliance or traceability. These identifiers help distinguish it from other pacemaker models in regulatory databases.