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

    SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE

    K Number: K884325 · Decision Apr 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    212
    Registration Numbers
    213
    Same Product Code
    496
    Applicant Total
    632
    Review Days
    193

    Basic Information

    Device Name
    SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
    K Number
    K884325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    October 14, 1988
    Decision Date
    April 25, 1989
    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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