Model D Bipolar Endocardial Lead

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

510(k) Number

K811876 ↗

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. →

• Is the Model D Bipolar Endocardial Lead designed for reuse in multiple patients or is it intended for single-use only?

  The Model D Bipolar Endocardial Lead is explicitly designed for single-use implantation in cardiovascular procedures. This is confirmed by its classification as a permanent pacemaker electrode intended for endocardial use, where sterility and one-time use are critical to prevent infection and ensure reliability during implantation.

• How should the Model D Bipolar Endocardial Lead be stored to maintain its sterility and integrity?

  Since the lead is supplied sterile, it must be stored and handled according to sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, away from contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Avoid exposure to moisture, direct sunlight, or physical damage.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?

  The Model D Bipolar Endocardial Lead received FDA 510(k) clearance (K811876) under the Traditional pathway, declared *Substantially Equivalent (SESE)* by the Cardiovascular Advisory Committee. This means the FDA determined it is as safe and effective as a legally marketed predicate device (a previously cleared lead) and meets Class III medical device standards. The clearance reflects rigorous review by the FDA and the advisory committee.

• What are the key differences between this bipolar lead and a unipolar lead in terms of its clinical function?

  The bipolar configuration of this lead uses two electrodes (rather than one in unipolar leads) to create a more precise electrical circuit for pacing and sensing cardiac signals. This design reduces noise interference, improves signal clarity, and enhances accuracy in detecting and managing cardiac rhythms, particularly in complex arrhythmias or when implanted in challenging anatomical locations.