Model C Unipolar Endocardial Lead

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

510(k) Number

K811877 ↗

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 Model C Unipolar Endocardial Lead and how does it function in the body?

  The Model C Unipolar Endocardial Lead is designed to deliver electrical stimulation directly to the endocardium (the inner lining of the heart chambers) to regulate heart rhythm. It is used in patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper pacing by transmitting controlled electrical impulses to maintain a consistent heartbeat.

• Is this lead intended for single-use or can it be reused after implantation?

  The Model C Unipolar Endocardial Lead is explicitly intended for single-use implantation only. It is supplied sterile and meant for one-time use in cardiac pacing procedures, adhering to clinical best practices for infection control and device performance.

• How is the lead supplied, and what should clinicians consider when handling it?

  The lead is supplied sterile and packaged for clinical use by trained medical professionals. Since it is single-use, clinicians must ensure proper aseptic techniques during implantation to prevent contamination. The sterile packaging protects the lead until immediate use, and any unused portions should be discarded per facility protocols.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Model C Unipolar Endocardial Lead received FDA 510(k) clearance through the traditional review pathway, determined to be *substantially equivalent* to a predicate device. The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the classification under FDA’s device code for permanent pacemaker electrodes (DTB).

• Are there multiple sizes or models available for this lead, and how would a clinician determine the correct one for a patient?

  While the provided data lists multiple FEI numbers (e.g., 3002618605, 1028232) associated with this lead, these are registration identifiers rather than distinct size or model variations. The lead itself is a single design (Model C) intended for unipolar endocardial pacing. Selection should be based on clinical indication, patient anatomy, and compatibility with the implanted pacemaker system, as determined by the physician.