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

    ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER

    K Number: K080360 · Decision Apr 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    5
    Review Days
    57

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    Basic Information

    Device Name
    ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
    K Number
    K080360
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endologix, Inc.
    Date Received
    February 11, 2008
    Decision Date
    April 8, 2008
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Endologix, Inc.

    K Number Device Name
    K120212 AFX INTRODUCER SYSTEM
    K111747 ENDOLOGIX AFX INTRODUCER SYSTEM
    K110090 AFX INTRODUCER SYSTEM
    K991601 DUAL LUMEN CATHETER, MODEL DL-35-90