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

    Thrombuster II Aspiration Catheter

    K Number: K213166 · Decision Oct 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Thrombuster II Aspiration Catheter
    K Number
    K213166
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaneka Medical America, LLC
    Date Received
    September 28, 2021
    Decision Date
    October 26, 2021
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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