BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

    K Number: K143102 · Decision Jul 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    268

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    Basic Information

    Device Name
    Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
    K Number
    K143102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
    Date Received
    October 29, 2014
    Decision Date
    July 24, 2015
    Product Code
    NIE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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