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

    EkoSonic Endovascular Device with Control Unit 4.0

    K Number: K183361 · Decision Apr 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    122

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    Basic Information

    Device Name
    EkoSonic Endovascular Device with Control Unit 4.0
    K Number
    K183361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Btg International, Inc.
    Date Received
    December 4, 2018
    Decision Date
    April 5, 2019
    Product Code
    QEY
    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
    QEY Mechanical Thrombolysis Catheter

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    Other Clearances by Btg International, Inc.

    K Number Device Name
    K191119 EkoSonic Endovascular Device
    K182324 EkoSonic Endovascular System
    K172035 EKOS ultrasound EVD Device, EVD Control Unit
    K162771 EkoSonic Endovascular System with Control Unit 4.0
    K140151 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT