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

    TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

    K Number: K140775 · Decision Jul 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    2
    Review Days
    117

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    Basic Information

    Device Name
    TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
    K Number
    K140775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectranetics Corporation
    Date Received
    March 28, 2014
    Decision Date
    July 23, 2014
    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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