Cardiac Pulse Generator, 16 Series

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

510(k) Number

K790867 ↗

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 Cardiac Pulse Generator, 16 Series, and how does it function in patients?

  The Cardiac Pulse Generator, 16 Series, is designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, helping to maintain proper cardiac function through consistent pacing signals.

• Is the Cardiac Pulse Generator, 16 Series, intended for reuse or is it single-use only?

  The device is supplied sterile and intended for single-use only, meaning it should not be reused after implantation. This ensures patient safety and compliance with regulatory standards for implantable devices.

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

  The Cardiac Pulse Generator, 16 Series, received FDA clearance through a 510(k) submission (K790867) under the Traditional clearance type, with a decision of Substantially Equivalent (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in regulating heart rhythm.

• Are there any special handling or storage requirements for this device before implantation?

  Since the device is supplied sterile and intended for single-use, it should be stored in its original packaging until ready for use to maintain sterility. No specific storage conditions (like temperature) are mentioned in the data, but standard medical device storage practices—such as protection from contamination and extreme temperatures—should be followed.

• What types of patients or clinical settings is this device most commonly used in?

  This device is intended for surgical implantation in patients with bradycardia or conduction disorders, meaning it is primarily used in cardiovascular settings like hospitals, cardiac clinics, or electrophysiology labs. It is not indicated for acute care or non-implantable applications.