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

    QuickClear Mechanical Thrombectomy System

    K Number: K193197 · Decision Apr 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    7
    Review Days
    152

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    Basic Information

    Device Name
    QuickClear Mechanical Thrombectomy System
    K Number
    K193197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volcano Atheromed, Inc.
    Date Received
    November 20, 2019
    Decision Date
    April 20, 2020
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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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
    K182972 Phoenix Atherectomy System
    K181877 Phoenix 2.4mm Atherectomy Plus 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