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

    HURWITZ DIALYSIS CATHETER

    K Number: K860094 · Decision Apr 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    75
    Review Days
    87

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    Basic Information

    Device Name
    HURWITZ DIALYSIS CATHETER
    K Number
    K860094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gish Biomedical, Inc.
    Date Received
    January 10, 1986
    Decision Date
    April 7, 1986
    Product Code
    LFJ
    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
    LFJ Catheter, Subclavian

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