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

    ComboCath OTW PTA Dilatation Catheter

    K Number: K150452 · Decision Aug 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    ComboCath OTW PTA Dilatation Catheter
    K Number
    K150452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Summa Therapeutics, LLC
    Date Received
    February 20, 2015
    Decision Date
    August 13, 2015
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by Summa Therapeutics, LLC

    K Number Device Name
    K230263 Finesse™ Injectable PTA Balloon Dilatation Catheter