Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K173423
    Device Name
    MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
    Manufacturer
    Date Cleared
    2017-11-17

    (16 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nano4Imaging GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
    Device Description
    The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
    Ask a Question

    Ask a specific question about this device

    K Number
    K160594
    Device Name
    MRWire Guide Wire
    Manufacturer
    Date Cleared
    2016-11-22

    (266 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANO4IMAGING GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
    Device Description
    The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle. The distal tip of the MRWire is marked with discrete ring markers for MRI visibility and comes in different configurations such as straight and angled. Additionally, the Pebax® tip extrusion, contains BaSO4 for X-Ray visibility. Guide wires are supplied sterile and non-pyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1