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

    CAPERE Thrombectomy System

    K Number: K192935 · Decision Nov 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    CAPERE Thrombectomy System
    K Number
    K192935
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Medcure, Inc.
    Date Received
    October 17, 2019
    Decision Date
    November 15, 2019
    Product Code
    QEW
    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
    QEW Peripheral Mechanical Thrombectomy With Aspiration

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    Other Clearances by Vascular Medcure, Inc.

    K Number Device Name
    K203476 CAPERE Thrombectomy System
    K201216 CAPERE Thrombectomy System
    K200314 Capere Thrombectomy System
    K183179 CAPERE Thrombectomy System