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

    LMI THROMBECTOMY CATHETER

    K Number: K970657 · Decision Jul 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    7
    Review Days
    130

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    Basic Information

    Device Name
    LMI THROMBECTOMY CATHETER
    K Number
    K970657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lucas Medical, Inc.
    Date Received
    February 21, 1997
    Decision Date
    July 1, 1997
    Product Code
    DXE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXE Catheter, Embolectomy

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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)
    K955126 LMI BILIARY CATHETER
    K954760 LMI ARTERIAL EMBOLECTOMY CATHETER
    K955125 LMI OCCLUSION CATHETER
    K955499 LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER