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510(k) Data Aggregation

    K Number
    K260188

    Validate with FDA (Live)

    Device Name
    LimFlow Vector
    Manufacturer
    LimFlow, Inc.
    Date Cleared
    2026-03-18

    (55 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K221902
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

    Device Description

    The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.

    AI/ML Overview

    N/A

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