Atrial Endocardial Electrode Lead J-Tip

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

510(k) Number

K813134 ↗

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

• 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 Atrial Endocardial Electrode Lead J-Tip and how does its design contribute to its function?

  The Atrial Endocardial Electrode Lead J-Tip is designed for permanent endocardial placement within the atrium to provide reliable electrical pacing. Its J-shaped tip enhances stability and positioning, ensuring consistent contact with the atrial wall for effective cardiac pacing. This design reduces displacement risk, which is critical for long-term functionality in pacemaker systems.

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

  The Atrial Endocardial Electrode Lead J-Tip is explicitly described as a reusable medical implant. It is intended for permanent placement within the body, meaning it is not disposable and is meant to remain implanted long-term as part of a cardiac pacing system.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  This device received FDA clearance under the Traditional 510(k) review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed in the U.S. for its intended use in cardiac pacing systems, adhering to FDA’s standards for permanent pacemaker electrodes.

• How is this device supplied, and what should clinicians consider when handling it?

  The device is supplied as a reusable implant, meaning it is not pre-packaged for single-use procedures. Clinicians should follow sterile handling protocols during implantation, as it is intended for direct endocardial placement within the atrium. Proper storage and maintenance are critical to ensure its reliability and longevity as a permanent component of a pacing system.