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

    RESOLUTION ENDOVASCULAR SYSTEM

    K Number: K052428 · Decision Dec 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    8
    Review Days
    97

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    Basic Information

    Device Name
    RESOLUTION ENDOVASCULAR SYSTEM
    K Number
    K052428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omnisonics Medical Technologies
    Date Received
    September 2, 2005
    Decision Date
    December 8, 2005
    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 Omnisonics Medical Technologies

    K Number Device Name
    K083335 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
    K071762 OMNIWAVE ENDOVASCULAR SYSTEM
    K041705 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
    K003824 OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
    K993628 OMNISONICS ULTRASONIC PROBES
    K993445 OMNISONIC ENDOSCOPIC DEFLECTOR
    K991377 OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER