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

    WOLF Thrombectomy V System

    K Number: K200101 · Decision Apr 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    140
    Applicant Total
    5
    Review Days
    101

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    Basic Information

    Device Name
    WOLF Thrombectomy V System
    K Number
    K200101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devoro Medical, Inc.
    Date Received
    January 17, 2020
    Decision Date
    April 27, 2020
    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 Devoro Medical, Inc.

    K Number Device Name
    K241207 SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
    K221391 WOLF Thrombectomy™ SmartClaw Catheter
    K210911 WOLF Thrombectomy System, 14F
    K210530 WOLF Thrombectomy System, 6F