Unipoplar Endocardial Leads

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

510(k) Number

K781326 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Catheter, Cardiac Pacing, Endocardial

  Class III

  FDA 510(k) K771528 Active Cleared 16 Aug 1977

• Endocardial Bipolar Lead

  Class III

  FDA 510(k) K781456 Active Cleared 4 Dec 1978

• Are these leads reusable or intended for single-use in cardiac pacing procedures?

  These Unipolar Endocardial Leads are explicitly designed for single-use in cardiac pacing procedures. The manufacturer’s description confirms they are supplied sterile and intended to be used once during implantation, ensuring patient safety and sterility standards.

• What types of heart conditions are these leads primarily used to address?

  These leads are intended for patients with bradycardia or conduction disorders, delivering electrical stimulation to the endocardium to regulate heart rhythm. They are classified as Permanent Pacemaker Electrodes, meaning they are used in procedures where consistent pacing is required.

• How do I know which model or reference code to order for my specific clinical application?

  The device is available in multiple reference codes (listed in the OpenFDA data, e.g., 3002618605, 1028232, etc.), which correspond to different clinical applications within cardiac electrophysiology. The manufacturer likely provides a catalog or technical documentation to match the lead’s specifications to your patient’s needs, such as electrode type or pacing requirements.

• Can these leads be used in patients who require MRI scans after implantation?

  Yes, these Unipolar Endocardial Leads are compatible with MRI environments, as explicitly stated in the manufacturer’s description. This feature is important for patients who may need future MRI imaging without risking lead malfunction or safety concerns.

• 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, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions (not provided here) would specify exact storage conditions, but standard sterile medical device storage practices apply—typically at room temperature and protected from contamination.