Cardiac Pulse Generator Model 160B

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

510(k) Number

K780113 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of the Model 160B Cardiac Pulse Generator, and how does it function in a clinical setting?

  The Model 160B Cardiac Pulse Generator is an implantable pacemaker designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle. It is intended for patients who require cardiac pacing support, helping to maintain a proper heartbeat when the heart’s natural conduction system is impaired or non-functional.

• Is the Model 160B intended for single-use or reusable applications, and what does this mean for its handling?

  The Model 160B is classified as a reusable device, meaning it is intended for surgical implantation and can be used multiple times after proper cleaning, sterilization, and maintenance. Since it is implanted, sterile handling during surgery is critical to prevent infection and ensure functionality.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

  The Model 160B received a Traditional 510(k) clearance through the Cardiovascular Advisory Committee, demonstrating it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator.

• How should the Model 160B be stored to maintain its integrity and functionality before implantation?

  Since the Model 160B is intended for sterile surgical implantation, it must be stored in a clean, controlled environment that preserves its sterility and prevents contamination. Proper packaging and adherence to manufacturer guidelines for storage conditions are essential to ensure the device remains functional and safe for use.