Focus T41, T41F, T43, T43F, T44F

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

510(k) Number

K904255 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

• Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K894267 Active Cleared 20 Sep 1989

See all devices from Ela Medical, Inc. →

• Are these pacemaker electrodes reusable or intended for single-use, and how should they be handled before implantation?

  The Focus T41, T41F, T43, T43F, and T44F electrodes are sterile and intended for single-use only. They come pre-packaged to maintain sterility and must be used immediately after opening by qualified healthcare professionals during implantation. Reuse is not recommended or supported by the manufacturer.

• What sizes or models are available, and how do I determine which one is best suited for my patient?

  The Focus series includes four models: T41, T41F, T43, T43F, and T44F, each designed with different configurations to accommodate varying patient anatomies and clinical needs. The ‘F’ variants (e.g., T41F) likely denote specific features like fixation mechanisms or lead designs. Selection should be based on the patient’s anatomy, implantation site (e.g., right ventricle or atrium), and the physician’s preference for pacing stability. Consult the manufacturer’s documentation or a product guide for detailed sizing and compatibility.

• Can these electrodes be used in patients who require MRI scans, and if so, are there any restrictions?

  Yes, the Focus T-series electrodes are compatible with MRI environments under specific conditions. However, the exact parameters (e.g., MRI machine type, field strength, and imaging sequences) must be followed to ensure safety. Always verify the manufacturer’s MRI safety guidelines and consult radiology staff before proceeding, as improper use could pose risks to the patient or device.

• How were these devices approved by the FDA, and what does the ‘510(k) clearance’ mean for clinicians?

  The Focus T-series electrodes received FDA 510(k) clearance through a traditional review process, meaning they were determined to be substantially equivalent to a legally marketed predicate device (a previously approved pacemaker electrode). This classification ensures they meet FDA safety and effectiveness standards for permanent pacemaker electrodes. Clinicians can rely on this approval as evidence of regulatory scrutiny, though individual cases should still follow standard implantation protocols.

• What storage conditions are recommended for these electrodes before use?

  While the data does not specify exact storage conditions, all sterile single-use medical devices—including these electrodes—typically require protection from moisture, extreme temperatures, and physical damage before use. Store them in their original, sealed packaging in a clean, dry environment as directed by the manufacturer’s instructions for use (IFU). Avoid exposure to direct sunlight or humidity, which could compromise sterility.