Pulse Generator, Litkicron Model 3-70H

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

510(k) Number

K770507 ↗

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

• 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

See all devices from Medcor, Inc. →

• What is the primary purpose of the Pulse Generator, Litkiron Model 3-70H, and how does it function in a clinical setting?

  The Pulse Generator, Litkiron Model 3-70H, is designed to regulate heart rhythm by delivering electrical impulses to patients with bradycardia or other cardiac conduction disorders. It is an implantable pacemaker intended for surgical implantation, providing life-sustaining support by maintaining proper heart rate and rhythm when the heart’s natural electrical system fails.

• Is the Pulse Generator, Litkiron Model 3-70H, intended for single-use or can it be reused after sterilization?

  The device is supplied sterile for single-use only, meaning it is not designed or cleared for reprocessing or reuse. Sterility is maintained for surgical implantation, and adherence to sterile medical device protocols is required during handling and storage.

• What storage and handling precautions should be taken for the Pulse Generator, Litkiron Model 3-70H?

  Since the device is sterile and intended for single-use, it must be stored in accordance with sterile medical device protocols to preserve its integrity. Avoid exposure to moisture, extreme temperatures, or contamination until implantation. Always follow manufacturer guidelines for packaging and shelf life.

• How is the regulatory status of this device determined, and what does that mean for clinicians?

  The Pulse Generator, Litkiron Model 3-70H, is classified as a Class III medical device under FDA regulations and holds a 510(k) clearance (K770507). This classification reflects its role in life-sustaining functions, and the clearance confirms it is *substantially equivalent* to a legally marketed device. Clinicians can rely on this approval for safety and performance, though they should always verify current regulatory status before use.

• What should clinicians know about MRI compatibility with this pulse generator?

  The Pulse Generator, Litkiron Model 3-70H, is labeled as MRI-unspecified, meaning its safety in MRI environments has not been explicitly defined. Clinicians must consult the manufacturer’s guidelines and evaluate risks carefully before exposing patients to MRI scans, as improper use could pose hazards to the device or patient.