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

    INTRAVENOUS CATHETER PLACEMENT UNIT &

    K Number: K823017 · Decision Nov 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    19

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    Basic Information

    Device Name
    INTRAVENOUS CATHETER PLACEMENT UNIT &
    K Number
    K823017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Access Devices, Inc.
    Date Received
    October 13, 1982
    Decision Date
    November 1, 1982
    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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    Other Clearances by Access Devices, Inc.

    K Number Device Name
    K823758 CENTRAL VEIN CATHERIZATION KIT
    K822834 ACCESS PERCUTANEOUS INTRODUCER SET