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

    DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811

    K Number: K100334 · Decision Apr 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    336
    Applicant Total
    3
    Review Days
    76

    Basic Information

    Device Name
    DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
    K Number
    K100334
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. BRAUN AVITUM AG
    Date Received
    February 5, 2010
    Decision Date
    April 22, 2010
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by B. BRAUN AVITUM AG

    K Number Device Name
    K102194 SOLCART B
    K083460 DIALOG WITH ADIMEA OPTION