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

    BD Centro Vena Acute Central Line (7 French Dual Lumen)

    K Number: K200266 · Decision Apr 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    BD Centro Vena Acute Central Line (7 French Dual Lumen)
    K Number
    K200266
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Access Systems, Inc. (Bard Has Joined Bd)
    Date Received
    February 3, 2020
    Decision Date
    April 7, 2020
    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 Bard Access Systems, Inc. (Bard Has Joined Bd)

    K Number Device Name
    K190855 BD Acute Central Line