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

    INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS

    K Number: K971339 · Decision Dec 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    25
    Review Days
    258

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    Basic Information

    Device Name
    INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
    K Number
    K971339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vascular Access, Inc.
    Date Received
    April 10, 1997
    Decision Date
    December 24, 1997
    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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