Implantable Unipolar Cardiac Pulse Gen

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

510(k) Number

K833428 ↗

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 Unipolar Cardiac Pulse Generator designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, stimulating the heart to maintain proper pacing and rhythm.

• Is this device meant for single-use or can it be reused after implantation?

  The device is sterile and intended for single-use only. It is not designed for reuse, and proper handling and storage must be followed to preserve sterility and functionality as specified by the manufacturer.

• How is this device supplied, and what regulatory pathway was used for its approval?

  The device is supplied as a sterile, implantable component in its original packaging. It was approved under the FDA 510(k) pathway with a Substantially Equivalent (SESE) determination, adhering to Class III regulatory standards for cardiovascular devices.

• What storage and handling precautions should be taken to ensure the device remains effective?

  The device must be stored and handled according to manufacturer guidelines to maintain sterility and functionality. Since it is single-use and implantable, proper packaging integrity and environmental controls (e.g., temperature, humidity) are critical before and during use.