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

    Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

    K Number: K191419 · Decision Sep 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
    K Number
    K191419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rex Medical, L.P.
    Date Received
    May 28, 2019
    Decision Date
    September 12, 2019
    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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