Atrial Endocardial Electrode Lead of J

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

510(k) Number

K811593 ↗

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

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• Is this lead designed for reuse in multiple patients or is it intended for single-use only?

  This lead is explicitly designed for single-use in cardiac pacing systems, as stated in the manufacturer’s description. It is supplied sterile and must be handled under clinical conditions to maintain sterility, which aligns with single-use guidelines.

• What makes the J-shaped tip of this lead important for its function?

  The J-shaped tip is engineered to provide stable positioning against the atrial wall, ensuring consistent and reliable electrical contact for pacing. This design minimizes displacement during cardiac contractions, improving long-term performance in atrial endocardial placement.

• How should this lead be stored before use, given its sterile packaging?

  Since the lead is supplied sterile, it must be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling and storage are critical to preserve sterility and functionality before clinical use.

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

  This lead received FDA 510(k) clearance under the classification of *DTB (Dental, Biologicals, and Specialty Products)* with a *Traditional* clearance type. The decision was made by the Cardiovascular (CV) Advisory Committee and classified as *Substantially Equivalent (SESE)*, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms its compliance with U.S. regulations for permanent pacemaker electrodes.