Implant Program Cardiac Pulse Gen W/Mod Set Screw

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

510(k) Number

K853206 ↗

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 this device, and how does it function in a clinical setting?

  This device is an Implantable Pacemaker Pulse-Generator, designed to replace natural cardiac conduction when the heart’s electrical system fails. It generates periodic electrical pulses to stimulate the heart muscle, ensuring a consistent heartbeat when the patient’s own rhythm is insufficient. It is implanted surgically and used in cardiovascular applications to manage bradycardia or other conduction disorders.

• Is this device intended for single-use or can it be reused after sterilization?

  The device is reusable but is supplied in a non-sterile state. It requires proper sterilization before surgical implantation to ensure safety and efficacy. Sterilization must follow validated protocols to maintain device integrity and prevent contamination.

• How is this device regulated, and what does the FDA clearance indicate about its safety and performance?

  This device was cleared under FDA 510(k) K853206 in 1985 as a Class III medical device, classified under product code DXY and regulated under 21 CFR 870.3610. The clearance indicates it was determined to be substantially equivalent to a legally marketed predicate device at the time, meaning it met FDA standards for safety, effectiveness, and performance for its intended use in pacemaker therapy.

• What storage or handling precautions should be taken before surgical use?

  Since this device is non-sterile and reusable, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, it requires sterilization via an approved method (e.g., ethylene oxide, autoclave, or gamma irradiation) to ensure sterility and functionality. Follow manufacturer guidelines for sterilization cycles and storage conditions to prevent damage or contamination.