Cardiac Pulse Generator 250B

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

Full name

Generator, Cardiac Pulse, 250B

510(k) Number

K781090 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  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

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  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

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  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 250B and which patients would benefit from it?

  The Cardiac Pulse Generator 250B is designed to regulate abnormal heart rhythms by delivering timed electrical impulses to the heart muscle. It is intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper cardiac function through electrical stimulation.

• Is this device meant for repeated use or is it intended for single-use implantation?

  The Cardiac Pulse Generator 250B is explicitly designed for single-use implantation. Once implanted, it is not intended to be removed or reused, aligning with its classification as a high-risk, life-sustaining device.

• How is the Cardiac Pulse Generator 250B supplied, and what precautions should be taken during handling?

  The device is supplied sterile and intended for surgical implantation by qualified healthcare professionals. Since it is a sterile, single-use implant, proper aseptic techniques must be followed during handling and implantation to prevent contamination.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The Cardiac Pulse Generator 250B underwent a Traditional 510(k) review through the FDA’s Cardiovascular (CV) Advisory Committee. It is classified as a Class III medical device due to its high-risk, life-sustaining nature, requiring premarket approval (PMA) or 510(k) clearance under product code DXY. The clearance number is K781090, and it adheres to regulatory standards outlined in 21 CFR 870.3610.