Laserpor Ap Atrial Endocard. Electr. Ld.

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

510(k) Number

K820121 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

• Implantable Electrode Lead, Model 030-446

  Class III

  FDA 510(k) K874664 Active Cleared 31 May 1988

See all devices from Telectronics, Inc. →

• What is the primary purpose of the Laserpor AP Atrial Endocardial Electrode Lead and where is it placed in the body?

  The Laserpor AP Atrial Endocardial Electrode Lead is designed for permanent implantation within the atrium of the heart. It delivers electrical impulses to regulate abnormal heart rhythms, specifically for cardiac pacing applications. This positioning ensures precise stimulation of the atrial chamber to maintain proper heart rhythm.

• Is this device intended for single-use or can it be reused? What are the considerations for reuse?

  The Laserpor AP Atrial Endocardial Electrode Lead is supplied sterile and intended for single-use implantation. However, it may be reused under specific clinical conditions as determined by the healthcare provider, depending on factors like sterility maintenance, structural integrity, and patient-specific needs.

• How should this device be stored before use, and what precautions should be taken?

  The device must be stored in its original packaging until use to ensure sterility and functionality. The packaging protects it from contamination and environmental factors that could compromise its performance or safety.

• Is this device compatible with MRI environments? If so, what conditions apply?

  Yes, the Laserpor AP Atrial Endocardial Electrode Lead is compatible with MRI environments under controlled conditions. The specific guidelines for MRI use are detailed in the device’s technical documentation, which should be consulted to ensure safe and effective operation during imaging.