Model A Unipolar Endocardial Lead

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

510(k) Number

K811879 ↗

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 A Unipolar Endocardial Lead, and how does it function in a patient’s body?

  The Model A Unipolar Endocardial Lead is designed to regulate heart rhythm in patients with bradycardia or related disorders by delivering electrical impulses to the inner lining of the heart (endocardium). It is implanted as part of a pacemaker system to stimulate the heart when its natural electrical signals are insufficient, ensuring consistent and appropriate contractions.

• Is this lead intended for single-use or can it be reused across multiple patients?

  The Model A Unipolar Endocardial Lead is explicitly intended for single-patient use following sterile preparation. While it is supplied as a reusable component in a clinical setting, it must not be reused for another patient after initial use to maintain sterility and safety standards.

• How is this device regulated by the FDA, and what does the product code DTB signify?

  The Model A Unipolar Endocardial Lead is classified as a Class III medical device under FDA regulation 870.3680 and has received FDA 510(k) clearance (K811879), meaning it has been determined to be substantially equivalent to a legally marketed predicate device. The product code DTB categorizes it under the FDA’s Permanent Pacemaker Electrode classification, aligning with cardiovascular medical specialty standards.

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

  Yes, the Model A Unipolar Endocardial Lead is compatible with MRI environments, though specific safety protocols must be followed as outlined in the device’s technical documentation. Always adhere to the manufacturer’s guidelines and MRI facility protocols to ensure patient safety during imaging.

• What storage requirements should be followed for this lead before implantation?

  While the provided data does not specify exact storage conditions, as a sterile, single-use medical device, the Model A Unipolar Endocardial Lead should be stored in its original packaging in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain sterility and functionality.