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

    FLU VEN I.V. SETS

    K Number: K811914 · Decision Aug 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    33

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    Basic Information

    Device Name
    FLU VEN I.V. SETS
    K Number
    K811914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Venusa , Ltd.
    Date Received
    July 1, 1981
    Decision Date
    August 3, 1981
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    K905518 BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET
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    K812981 FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)