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

    EXEL HUBER INFUSION SET ROTATING WING

    K Number: K926119 · Decision Aug 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    18
    Review Days
    251

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    Basic Information

    Device Name
    EXEL HUBER INFUSION SET ROTATING WING
    K Number
    K926119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exel Intl.
    Date Received
    December 3, 1992
    Decision Date
    August 11, 1993
    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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    K903945 EXEL A-V FISTULA SET
    K895770 EXEL HUBER INFUSION SET
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    K895772 EXEL INDWELLING CATHETER
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