Unipolar-E Endocardial Tined Lead

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

510(k) Number

K832245 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• What is the primary purpose of the Unipolar-E Endocardial Tined Lead in cardiac procedures?

  The Unipolar-E Endocardial Tined Lead is designed for endocardial implantation to deliver unipolar pacing stimulation to the heart’s inner lining. This helps regulate heart rhythm in patients with arrhythmias by providing consistent electrical impulses, while the tined structure ensures secure fixation within the cardiac chamber to minimize displacement risk.

• Is this lead intended for reuse, or is it meant to be used only once during a procedure?

  The Unipolar-E Endocardial Tined Lead is explicitly supplied sterile and intended for single-use implantation. Reuse is not recommended, as it could compromise sterility and patient safety, aligning with standard practices for permanent pacemaker electrodes.

• How should this lead be stored to maintain its integrity before use?

  The lead must be stored according to the manufacturer’s guidelines to preserve sterility. Since it is supplied sterile and intended for single-use, it should remain in its original packaging until immediately before implantation, avoiding exposure to contaminants or environmental conditions that could compromise its sterile state.

• Are there multiple models or reference codes available for this lead, and how do I identify the correct one for my procedure?

  Yes, the Unipolar-E Endocardial Tined Lead is available in multiple reference codes, including 3002618605, 3008377825, and others listed in the FDA registry. The correct model should be selected based on clinical requirements (e.g., lead length, coil specifications) and compatibility with your pacemaker system. Always verify the specific code with your supplier or manufacturer to ensure proper fit and function.

• Can this lead be used in patients who require MRI scans, and what regulatory considerations apply?

  The Unipolar-E Endocardial Tined Lead is classified under the DTB (Defibrillator/Temporary Pacing) product code, which indicates compatibility with MRI environments. However, MRI use must follow strict protocols to avoid risks like lead displacement or heating. Always consult the manufacturer’s guidelines and your institution’s MRI safety policies before proceeding.