Np Bipolar Endocardial Lead W/Vs-1 Connector

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

510(k) Number

K875199 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

  Class III

  FDA 510(k) K833098 Active Cleared 19 Oct 1983

• Biotronik D2K Unipolar PE-60/4

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  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

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  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

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  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What is the NP Bipolar Endocardial Lead with VS-1 Connector used for in clinical practice?

  This device is designed specifically for endocardial pacing, delivering electrical stimulation to the inner lining of the heart to help regulate abnormal cardiac rhythms in patients who require pacing support. It is intended for use in procedures where permanent pacemaker electrodes are implanted to maintain proper heart function.

• Is the NP Bipolar Endocardial Lead with VS-1 Connector meant for single-use or can it be reused?

  The device is explicitly labeled as single-use, meaning it is intended for one-time use during a cardiac electrophysiology procedure. Reuse is not recommended or supported by the manufacturer.

• How is the NP Bipolar Endocardial Lead with VS-1 Connector supplied, and is it sterile?

  The lead is supplied sterile, ensuring it is ready for immediate use in sterile cardiac procedures. This is critical for preventing infection during implantation.

• What type of connector does this lead use, and how does that affect compatibility?

  This lead features a VS-1 connector, which is a specific interface designed for compatibility with certain pacemaker systems. The connector type ensures proper electrical connection and signal transmission between the lead and the pacemaker device, so compatibility must be verified with your chosen pacemaker system.

• How was the regulatory approval for this device obtained, and what does that mean for clinicians?

  The NP Bipolar Endocardial Lead received FDA 510(k) clearance (K875199) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent to a predicate device. This means it was evaluated by the FDA’s Cardiovascular (CV) Advisory Committee and determined to meet safety and effectiveness standards for permanent pacemaker electrodes. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow manufacturer guidelines and institutional protocols for proper use.