Implantable Program. Cardiac Pulse Gen

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

510(k) Number

K831771 ↗

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 the body?

  This device is an Implantable Pacemaker Pulse-Generator, designed to regulate and stimulate the heartbeat in patients with cardiac rhythm disorders. It works by generating electrical impulses to maintain proper heart function, ensuring consistent contractions of the heart chambers when the body’s natural pacemaker fails or malfunctions.

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

  The device is sterile and intended for single-use implantation only. It is supplied pre-sterilized, ready for surgical placement within the body without requiring additional sterilization procedures.

• What regulatory pathway was followed for this device’s approval, and which medical specialty does it belong to?

  This device was cleared through the FDA 510(k) pathway under Traditional Review, classified as a Class III device (regulation 870.3610) and falls under the Cardiovascular medical specialty. The clearance number is K831771, and it was determined to be substantially equivalent to a predicate device.

• Are there any specific details about the device’s sizing or customization options for patients?

  The provided data does not specify sizing options, customization, or patient-specific adaptations for this implantable pulse generator. Standard models are implied, but exact dimensions or variability in design are not detailed.