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

    EkoSonic Endovascular System with Control Unit 4.0

    K Number: K162771 · Decision Feb 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    6
    Review Days
    144

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EkoSonic Endovascular System with Control Unit 4.0
    K Number
    K162771
    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
    October 3, 2016
    Decision Date
    February 24, 2017
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QEY), ordered by most recent decision date.

    Versus™ Catheter (VS110-9NB)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VariFuse Adjustable Infusion Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Versus™ Catheter (VS110-8B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EKOS+ Endovascular Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Btg International, Inc.

    K Number Device Name
    K191119 EkoSonic Endovascular Device
    K183361 EkoSonic Endovascular Device with Control Unit 4.0
    K182324 EkoSonic Endovascular System
    K172035 EKOS ultrasound EVD Device, EVD Control Unit
    K140151 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT