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    K Number
    K171146
    Device Name
    Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
    Manufacturer
    Arrow International, Inc. (Subsidiary of Telelflex Inc.)
    Date Cleared
    2017-06-23

    (65 days)

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

    Arrow International, Inc. (Subsidiary of Telelflex Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
    Device Description
    The subject Arrow Seldinger Arterial Catheterization Devices consist of either an introducer needle or catheter-over-needle assembly, spring wire guide, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a luer hub with dust cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique.
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