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

    START IT WITH & WITHOUT I.V. CATH. UNIT

    K Number: K801537 · Decision Sep 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    START IT WITH & WITHOUT I.V. CATH. UNIT
    K Number
    K801537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pioneer Viggo, Inc.
    Date Received
    July 3, 1980
    Decision Date
    September 19, 1980
    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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    K Number Device Name
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    K811171 VASCULON II I.V. CATHETER
    K791809 BLOOD TRANSFUSION MICROFILTER