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510(k) Data Aggregation

    K Number
    K221902
    Device Name
    LimFlow Vector
    Manufacturer
    LimFlow, Inc.
    Date Cleared
    2022-12-21

    (174 days)

    Product Code
    MGZ, LIM
    Regulation Number
    870.4885
    Why did this record match?
    Applicant Name (Manufacturer) :

    LimFlow, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K221541
    Device Name
    LimFlow ARC
    Manufacturer
    LimFlow, Inc.
    Date Cleared
    2022-08-31

    (96 days)

    Product Code
    PDU
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LimFlow, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The LimFlow ARC is a single-use device designed to facilitate placement and positioning of quide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.
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