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

    CLEANER ROTATIONAL THROMBECTOMY SYSTEM

    K Number: K060904 · Decision Apr 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    8
    Review Days
    25

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    Basic Information

    Device Name
    CLEANER ROTATIONAL THROMBECTOMY SYSTEM
    K Number
    K060904
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rex Medical, L.P.
    Date Received
    April 3, 2006
    Decision Date
    April 28, 2006
    Product Code
    MCW
    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
    MCW Catheter, Peripheral, Atherectomy

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