Stela Model UJ45 Pacing Leads

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

510(k) Number

K972574 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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. →

• Are the Stela Model UJ45 Pacing Leads reusable or intended for single-use in clinical settings?

  The Stela Model UJ45 Pacing Leads are explicitly designed for single-use only. They are supplied sterile and intended to be used once in sterile surgical environments, ensuring patient safety and compliance with medical device standards.

• What types of configurations or sizes are available for the Stela Model UJ45 Pacing Leads?

  The Stela Model UJ45 Pacing Leads come in multiple configurations, differentiated by FEI numbers (e.g., 2017865, 3002618605, etc.). These FEI numbers correspond to specific lead designs, lengths, or electrode placements, allowing for flexibility in cardiac implantation based on patient needs.

• How should the Stela Model UJ45 Pacing Leads be stored before use?

  Since these leads are sterile and single-use, they must be stored in their original packaging until ready for use. Proper storage ensures sterility and integrity, which is critical for implantation in sterile surgical environments. Always follow manufacturer guidelines for handling and expiration.

• What regulatory pathway was followed for FDA clearance of the Stela Model UJ45 Pacing Leads?

  The Stela Model UJ45 Pacing Leads were cleared through the FDA’s 510(k) process, specifically under a Traditional Review with the Cardiovascular (CV) Advisory Committee. They are classified as Class III devices under regulation number 870.3680, indicating they are subject to stringent oversight due to their role in life-sustaining cardiac rhythm management.