Model B Bipolar Endocardial Lead

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

510(k) Number

K811878 ↗

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 B Bipolar Endocardial Lead in a pacemaker system?

  The Model B Bipolar Endocardial Lead is designed to deliver electrical impulses to the heart muscle while enabling both sensing and pacing functions. Its bipolar configuration allows for precise cardiac rhythm management, making it suitable for use within a pacemaker system to help regulate abnormal heartbeats.

• Is the Model B Bipolar Endocardial Lead intended for reuse or single-use after implantation?

  The Model B Bipolar Endocardial Lead is supplied sterile and intended for single-use implantation in the endocardium. It is not designed for reuse, adhering to regulatory standards for permanent pacemaker electrodes.

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

  The Model B Bipolar Endocardial Lead was cleared under the FDA 510(k) pathway (K811878) as *substantially equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for cardiovascular applications under 21 CFR 870.3680.

• How is the lead categorized in terms of medical specialty and regulatory classification?

  The Model B Bipolar Endocardial Lead falls under the cardiovascular medical specialty and is classified as a Class III medical device, reflecting its role in life-sustaining or life-supporting functions. It is regulated under product code DTB for permanent pacemaker electrodes, with oversight by the FDA’s Cardiovascular (CV) Advisory Committee.