Picf 0860/Pscf 0860/Psc 0860/Piaf 0860/Psaf 0860

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

510(k) Number

K872731 ↗

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. →

• Are these pacemaker electrodes designed for single-use or can they be reused after proper cleaning and sterilization?

  These electrodes (PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860) are explicitly labeled as reusable. The manufacturer, Ela Medical, Inc., states they must undergo appropriate cleaning and sterilization procedures before reuse, ensuring compliance with medical device reprocessing standards.

• What types of patients are these electrodes intended to support, and how do they function?

  These electrodes are designed for patients with bradycardia or conduction disorders requiring cardiac pacing. They deliver electrical impulses directly to the myocardium to regulate heart rhythm and maintain proper cardiac function, functioning as part of a permanent pacemaker system.

• How should these electrodes be stored before use, and what precautions should be taken?

  While the data does not specify storage conditions explicitly, these electrodes are intended for sterile surgical use. They should be stored in a clean, dry environment, protected from contamination, and handled with sterile techniques before implantation to ensure patient safety.

• Are these electrodes compatible with MRI imaging, and if so, under what conditions?

  Yes, these electrodes adhere to MRI safety standards, but compatibility depends on the specific imaging environment and settings. The design accounts for MRI safety, though final use must align with the manufacturer’s guidelines and the imaging facility’s protocols to avoid risks like heating or displacement.

• What regulatory pathway was followed for these electrodes, and what does that mean for their use?

  These electrodes were cleared through the FDA’s 510(k) pathway, specifically under the Traditional route, with a decision of Substantially Equivalent (SESE). This means they were determined to have the same intended use, technological characteristics, and performance as a legally marketed predicate device, ensuring they meet FDA safety and effectiveness standards for permanent pacemaker electrodes.