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510(k) Data Aggregation

    K Number
    K013384
    Device Name
    SHARGHP A.V. FISTULA NEEDLE SET
    Manufacturer
    SHARGH PHARMACEUTICAL CO., INC.
    Date Cleared
    2002-01-07

    (87 days)

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

    SHARGH PHARMACEUTICAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is an A.V. Fistula Needle Set part of extracorporial artificial kidney system This device is an A. V. Fistula Noodle Det part of claims of the patient's blood vessel for Hemodialysis.
    Device Description
    SHARghP A.V. Fistula Needle Set
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