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

    BARD FLEXIBLE TIP URETERAL CATHETER

    K Number: K950300 · Decision Apr 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    27
    Applicant Total
    645
    Review Days
    92

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    Basic Information

    Device Name
    BARD FLEXIBLE TIP URETERAL CATHETER
    K Number
    K950300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    January 25, 1995
    Decision Date
    April 27, 1995
    Product Code
    EYB
    Advisory Committee
    Gastroenterology, Urology
    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
    EYB Catheter, Ureteral, Gastro-Urology

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