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

    Phoenix 2.4mm Atherectomy Plus System

    K Number: K181877 · Decision Dec 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    7
    Review Days
    157

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    Basic Information

    Device Name
    Phoenix 2.4mm Atherectomy Plus System
    K Number
    K181877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volcano Atheromed, Inc.
    Date Received
    July 13, 2018
    Decision Date
    December 17, 2018
    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 Volcano Atheromed, Inc.

    K Number Device Name
    K211518 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
    K193197 QuickClear Mechanical Thrombectomy System
    K182972 Phoenix Atherectomy System
    K172386 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
    K151145 2.4mm X 127 cm Phoenix Atherectomy Deflecting System
    K143328 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip