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

    F.A.S.T. SYSTEM SED AND CXD

    K Number: K092623 · Decision Oct 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    2
    Review Days
    65

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    Basic Information

    Device Name
    F.A.S.T. SYSTEM SED AND CXD
    K Number
    K092623
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genesis Medical Interventional, Inc.
    Date Received
    August 26, 2009
    Decision Date
    October 30, 2009
    Product Code
    QEW
    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
    QEW Peripheral Mechanical Thrombectomy With Aspiration

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    Other Clearances by Genesis Medical Interventional, Inc.

    K Number Device Name
    K040010 GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS