Lithicron Model 3-70C-B Pulse Generator

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

510(k) Number

K771538 ↗

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 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 primary purpose of the Lithicron Model 3-70C-B Pulse Generator, and who should use it?

  The Lithicron Model 3-70C-B Pulse Generator is designed to deliver electrical impulses for regulating cardiac rhythm, serving as an implantable pacemaker. It is intended for use exclusively by trained medical professionals during surgical implantation procedures in clinical settings.

• Is this device single-use or reusable, and how is it supplied?

  The Lithicron Model 3-70C-B Pulse Generator is supplied sterile and intended for single-use only. This ensures patient safety and device reliability, as reuse is not supported by its design or regulatory classification.

• Can this device be used in an MRI environment, and why?

  No, the Lithicron Model 3-70C-B Pulse Generator is not MRI-safe. This is explicitly stated in the device documentation to prevent potential risks to patients, such as interference or damage to the device, which could compromise its function or lead to harm.

• What regulatory pathway was followed for this device, and what classification does it hold?

  The Lithicron Model 3-70C-B Pulse Generator was cleared through the FDA 510(k) pathway under clearance number K771538, with a decision of Substantially Equivalent (SESE). It is classified as a Class III medical device under regulation number 870.3610, reflecting its critical role in life-sustaining cardiac rhythm management.

• Where is this device manufactured, and what should be considered during handling?

  The device is manufactured by Medcor, Inc. based in McHenry, Illinois (USA). Due to its implantable nature, it must be handled with extreme care during surgical procedures to ensure proper functionality and patient safety, as outlined in its regulatory documentation.