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

    GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A

    K Number: K040301 · Decision Nov 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    24
    Review Days
    266

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    Basic Information

    Device Name
    GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
    K Number
    K040301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Gambro Renal Products
    Date Received
    February 9, 2004
    Decision Date
    November 1, 2004
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

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    K033262 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
    K043342 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
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