Model F Unipolar Endocardial Lead

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

510(k) Number

K832255 ↗

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

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  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

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  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

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• Model 325D Unipolar Cardiac Pulse Gen

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• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

• Model 325T Programmable Pulse Generator

  Class III

  FDA 510(k) K812358 Active Cleared 29 Oct 1981

See all devices from Cook Pacemaker Corp. →

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

  This Model F Unipolar Endocardial Lead is explicitly supplied sterile and intended for single-use implantation in cardiac electrophysiology procedures. It is not designed for reuse across patients, aligning with standard practices for permanent pacemaker electrodes to ensure patient safety and sterility.

• What types of heart conditions is this lead typically used to address, and how does it work?

  This lead is designed for patients with bradycardia or conduction disorders, delivering electrical stimulation to the endocardium to regulate heart rhythm. It functions as a permanent pacemaker electrode, transmitting impulses directly to the heart tissue to maintain proper pacing when the natural conduction system is impaired.

• How is this lead supplied, and what should clinicians verify before use?

  The lead is supplied sterile and comes pre-packaged for single-use procedures. Clinicians should verify the sterility seal is intact and confirm compatibility with their pacemaker system before implantation, as it is intended for use in cardiovascular settings only.

• What regulatory pathway does this device follow, and how does that affect its use?

  This lead follows the FDA 510(k) clearance pathway under product code DTB, classified as a Class III device for permanent pacemaker electrodes. The clearance (K832255) was granted in 1983 under the substantially equivalent determination, meaning it meets FDA standards for safety and effectiveness as a unipolar endocardial lead for cardiac pacing.

• Are there specific storage requirements for this lead before implantation?

  While the data does not specify storage conditions, as a sterile, single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Clinicians should follow manufacturer guidelines (available from Cook Pacemaker Corp.) to preserve sterility until use.