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

    DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

    K Number: K904558 · Decision Feb 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    50
    Review Days
    129

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    Basic Information

    Device Name
    DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
    K Number
    K904558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Davol, Inc.
    Date Received
    October 5, 1990
    Decision Date
    February 11, 1991
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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