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

    ASPIRE MAX ASPIRATION CATHETER

    K Number: K113757 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    ASPIRE MAX ASPIRATION CATHETER
    K Number
    K113757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Control Medical Technology, LLC
    Date Received
    December 21, 2011
    Decision Date
    February 22, 2012
    Product Code
    QEZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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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    Other Clearances by Control Medical Technology, LLC

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