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

    JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL

    K Number: K853701 · Decision Oct 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    51
    Review Days
    43

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    Basic Information

    Device Name
    JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
    K Number
    K853701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Critikon Company, LLC
    Date Received
    September 4, 1985
    Decision Date
    October 17, 1985
    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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