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

    HawkOne Directional Atherectomy System

    K Number: K161361 · Decision Oct 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    5
    Review Days
    151

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    Basic Information

    Device Name
    HawkOne Directional Atherectomy System
    K Number
    K161361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Vascular, Inc.
    Date Received
    May 16, 2016
    Decision Date
    October 14, 2016
    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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    Other Clearances by Medtronic Vascular, Inc.

    K Number Device Name
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