Catheter, Cardiac Pacing, Endocardial

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

510(k) Number

K771528 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Endocardial Bipolar Lead

  Class III

  FDA 510(k) K781456 Active Cleared 4 Dec 1978

• Unipoplar Endocardial Leads

  Class III

  FDA 510(k) K781326 Active Cleared 4 Dec 1978

• What is the primary purpose of this cardiac pacing catheter, and who is it designed for?

  This endocardial cardiac pacing catheter is designed to deliver electrical impulses to the heart muscle to regulate abnormal heart rhythms, specifically for patients requiring chronic cardiac pacing support. It is intended for individuals with conditions like bradycardia or heart block, ensuring proper heart function over an extended period.

• Is this catheter reusable, or is it meant for single-use only?

  The catheter is supplied sterile and intended for single-use, though some models may vary in design to ensure compatibility with specific pacing systems. Reuse is not recommended to maintain sterility and functionality as outlined by the manufacturer.

• How should this device be stored to ensure it remains effective and sterile?

  Storage and handling must strictly follow the manufacturer’s guidelines to preserve sterility and functionality. While no explicit MRI safety labeling is provided, proper storage conditions (e.g., sealed packaging, controlled temperature) are critical to maintaining device integrity before use.

• What regulatory pathway does this device follow, and how is it classified?

  This catheter is regulated under the FDA 510(k) clearance process (K771528) and falls under device classification III (870.3680) as a permanent pacemaker electrode. It was determined to be *substantially equivalent* to a predicate device and reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.

• Are there multiple sizes or models available for this catheter?

  Yes, multiple models are listed under the registration numbers (e.g., 3002618605, 1028232, etc.), suggesting variations in design or specifications to accommodate different pacing system compatibilities. Exact sizing details would require referencing the manufacturer’s documentation for each model.