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510(k) Data Aggregation

    K Number
    K040260
    Device Name
    INTEGRAL HEMODIALYSIS CATHETER
    Manufacturer
    ARROW INT'L.
    Date Cleared
    2004-03-05

    (30 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARROW INT'L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow® integral catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The integral catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The integral catheter is intended for use in adult patients.
    Device Description
    The Arrow integral hemodialysis catheter consists of a double lumen catheter with a molded juncture hub and two extension lines. This allows the catheter tip to be precisely positioned within the vein, similar to single lumen, dual catheters.
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