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

    X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER

    K Number: K080944 · Decision Oct 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    645
    Review Days
    203

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    Basic Information

    Device Name
    X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
    K Number
    K080944
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    April 3, 2008
    Decision Date
    October 23, 2008
    Product Code
    LJE
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJE Catheter, Nephrostomy

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