Pacing Leads Focus T81, T81F, T82F, T83, T83F, T84F

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

510(k) Number

K884394 ↗

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

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

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

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• What are the primary uses of the Pacing Leads Focus T81 series in clinical practice?

  The Pacing Leads Focus T81, T81F, T82F, T83, T83F, and T84F are designed for permanent implantation in the cardiovascular system to deliver electrical stimulation to the heart. They are specifically intended for patients with bradycardia or other pacing-dependent conditions, helping regulate heart rhythm by transmitting electrical impulses as part of a cardiac pacing system.

• Are these leads meant for single-use or can they be reused after implantation?

  These leads are explicitly supplied sterile and intended for single-use implantation only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• How are the different models (T81, T81F, etc.) distinguished, and what should clinicians consider when selecting one?

  Each model (T81, T81F, T82F, T83, T83F, T84F) is engineered for specific pacing applications, though the exact distinctions between them are not detailed in the provided data. Clinicians should refer to the manufacturer’s technical documentation to determine compatibility with their patient’s pacing needs, such as lead positioning or impedance requirements, before selection.

• What regulatory pathway was followed for FDA clearance of these pacing leads?

  The Pacing Leads Focus series received a Traditional 510(k) clearance (K884394) under the DTB product code, classified under FDA regulation 870.3680 for permanent pacemaker electrodes. The decision was made by the Cardiovascular (CV) Advisory Committee, confirming substantial equivalence to predicate devices under Class III standards.

• How should these leads be stored before use to maintain their sterility?

  Since the leads are supplied sterile, they should be stored in their original packaging as directed by the manufacturer to preserve sterility. Avoid exposure to moisture, extreme temperatures, or contamination until immediate use. Always check expiration dates and storage instructions provided by Ela Medical, Inc.