Models UL-804 and BL-801 Unipolar Leads

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K791552 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• Are these leads reusable or intended for single-use only, and how does that affect their sterility and handling requirements?

  The Models UL-804 and BL-801 Unipolar Leads are explicitly designed for single-use implantation within the cardiovascular system. They are supplied sterile, which means they must remain unopened and uncontaminated until use. Since they are not intended for reuse, proper sterile barrier packaging must be maintained, and any unused portion must be discarded according to medical device disposal protocols to prevent infection risks.

• What types of heart conditions are these leads intended to address, and how do they function within a pacing system?

  These leads are permanent pacemaker electrodes intended for patients with bradycardia or conduction disorders, where the heart’s natural electrical signals are insufficient to maintain an adequate rhythm. They deliver electrical impulses to the heart muscle to regulate contractions, ensuring proper pacing when the heart’s natural conduction system fails. They are part of a cardiac pacing system and work in conjunction with a pacemaker device.

• How are these leads categorized in terms of regulatory approval, and what does that mean for clinicians or hospitals purchasing them?

  The Models UL-804 and BL-801 Unipolar Leads are classified as Class III medical devices under FDA regulations (product code DTB) and hold a 510(k) clearance (K791552) with a Substantially Equivalent (SESE) determination from 1979. This means they meet stringent safety and effectiveness standards for permanent implantation in the cardiovascular system, ensuring they comply with FDA requirements for permanent pacemaker electrodes. Clinicians and hospitals can rely on this classification for assurance of regulatory compliance.

• What storage conditions should be followed for these leads to maintain their integrity before use?

  While the data does not specify exact storage conditions, as sterile, single-use medical devices, these leads should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. The original packaging should remain intact until immediately before use to preserve sterility. Always follow the manufacturer’s instructions (Pacesetter Systems) for optimal storage to prevent degradation or compromise of the device.