Lithicron F Programmable Pulse Gen

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

510(k) Number

K780430 ↗

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 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

• 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 clinical conditions is the Lithicron F Programmable Pulse Generator designed to address in patients?

  The Lithicron F Programmable Pulse Generator is designed to regulate heart rhythm in patients with bradycardia (slow heart rate) or conduction disorders, delivering timed electrical impulses to maintain consistent cardiac pacing. Its programmable settings allow adjustments to pacing rate, output, and timing parameters to meet individual patient needs.

• Is the Lithicron F Programmable Pulse Generator intended for reuse, or is it meant to be used only once?

  The Lithicron F Programmable Pulse Generator is explicitly designed for single-use only after surgical implantation. This ensures patient safety and sterility, as it is supplied sterile and packaged for clinical use without any indication of reprocessing or reuse.

• How should the Lithicron F Programmable Pulse Generator be stored to maintain its functionality and sterility?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and packaged for clinical use, proper handling—including protection from contamination, moisture, and extreme temperatures—is critical before and after implantation. Always follow Medcor’s storage instructions to avoid compromising performance.

• What regulatory pathway was followed for FDA clearance of the Lithicron F Programmable Pulse Generator?

  The Lithicron F Programmable Pulse Generator received FDA 510(k) clearance (K780430) under the traditional review pathway, classified as substantially equivalent to predicate devices. It falls under FDA classification DXY (Implantable Pacemaker Pulse-Generator) and adheres to regulation 870.3610, with review by the Cardiovascular (CV) Advisory Committee.

• Are there multiple models or sizes available for the Lithicron F Programmable Pulse Generator?

  The provided data does not specify distinct models or sizes for the Lithicron F Programmable Pulse Generator. However, it is classified as an implantable pacemaker pulse-generator, so its design likely accommodates standard pacing requirements for bradycardia or conduction disorders. For exact specifications, refer to Medcor’s official product documentation.