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

    LMI BILIARY CATHETER

    K Number: K955126 · Decision May 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    7
    Review Days
    183

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    Basic Information

    Device Name
    LMI BILIARY CATHETER
    K Number
    K955126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lucas Medical, Inc.
    Date Received
    November 9, 1995
    Decision Date
    May 10, 1996
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Lucas Medical, Inc.

    K Number Device Name
    K983802 LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
    K972623 LMI IRRIGATION CATHETER (IGR)
    K970657 LMI THROMBECTOMY CATHETER
    K954760 LMI ARTERIAL EMBOLECTOMY CATHETER
    K955125 LMI OCCLUSION CATHETER
    K955499 LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER