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510(k) Data Aggregation

    K Number
    K251318

    Validate with FDA (Live)

    Device Name
    VariFuse Adjustable Infusion Catheter
    Manufacturer
    Argon Medical Devices, Inc.
    Date Cleared
    2026-01-20

    (266 days)

    Product Code
    QEY
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K964868,K202347
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VariFuse Adjustable Infusion Catheter is indicated for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

    Device Description

    The VariFuse™ Adjustable disposable Infusion Catheter System consists of:

    • An adjustable infusion catheter is comprised of the outer and inner catheters pre-assembled coaxially and inseparable, set at the maximum infusion length (i.e. 50 cm) with a Touhy Borst Adapter for shipping.
      • The inner infusion catheter is designed with infusion holes spaced unevenly along the infusion length of 50 cm, a valve at the distal tip, and a radiopaque marker at the distal tip.
      • The outer infusion catheter is designed to set the infusion length by covering the infusion holes and contains a radiopaque marker at the distal tip.
    • A 1cc Luer Lock Syringe is included in the packaging for flushing
    AI/ML Overview

    N/A

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