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510(k) Data Aggregation

    K Number
    K071762
    Device Name
    OMNIWAVE ENDOVASCULAR SYSTEM
    Manufacturer
    OMNISONICS MEDICAL TECHNOLOGIES
    Date Cleared
    2007-09-27

    (90 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K050147,K050130,K050563,K052428
    Predicate For
    K083335
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

    Device Description

    The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the OmniWave Endovascular System, stating that it is substantially equivalent to predicate devices. It describes the device, its intended use, and lists predicate devices, but does not include details on specific device performance metrics or a study designed to test against acceptance criteria.

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