Leads Utiliz Volun Stand #1 3.2 Mm Uni/Biopolar Co

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

510(k) Number

K861440 ↗

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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• What is the primary purpose of this pacemaker electrode lead, and how does its design accommodate different clinical needs?

  This device is a Permanent Pacemaker Electrode designed to deliver electrical impulses for cardiac pacing, helping regulate heart rhythm in patients with bradycardia or conduction disorders. Its unipolar or bipolar configuration allows it to be paired with various pacemaker generators, ensuring flexibility to meet specific clinical requirements.

• Is this lead intended for single-use or reusable applications, and what precautions should be taken during handling?

  The lead is supplied sterile for single-use implantation only, meaning it should not be reused after one procedure. Since it is sterile, proper sterile medical device protocols must be followed during storage, handling, and implantation to prevent contamination.

• What size and compatibility features should clinicians consider when selecting this lead for a patient?

  This lead features a 3.2 mm diameter coil, making it compatible with standard pacemaker systems. The unipolar/bipolar design ensures versatility in pairing with different pacemaker generators, but clinicians should verify compatibility with their specific device before use.

• How is this device regulated, and what does the FDA’s classification mean for its use?

  This lead is classified as Class III under FDA regulations (21 CFR 870.3680), indicating it carries higher risk and requires strict oversight. It was cleared via the Traditional 510(k) pathway in 1986, meaning it was deemed substantially equivalent to a legally marketed predicate device at the time. This classification ensures rigorous review of its safety and effectiveness for cardiac pacing applications.