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510(k) Data Aggregation

    K Number
    K160770
    Device Name
    Vent-Os Sinus Dilation family
    Date Cleared
    2016-06-29

    (100 days)

    Product Code
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINUSYS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SinuSys Vent-Os® Sinus Dilation family is intended to provide a means to access the sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures. - The Vent-Os Maxillary Dilation System is indicated for dilation of Maxillary sinus and associated spaces. - · The Vent-Os Frontal Dilation System is indicated for dilation of the Frontal recess and associated spaces. - · The Vent-Os Sphenoid Dilation System is indicated for dilation of Sphenoid sinus and associated spaces.
    Device Description
    The Vent-Os® Sinus Dilation family comprises a family of osmotically driven devices that access and dilate the sinus ostia and spaces associated with the paranasal sinus cavities. Each member of the Vent-Os® Sinus Dilation family is a system that includes a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os® Sinus Dilation Device then expands and remodels the target tissues and then is removed.
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    K Number
    K133016
    Device Name
    VENT-OS SINUS DILATION SYSTEM
    Date Cleared
    2013-12-09

    (75 days)

    Product Code
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    SINUSYS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vent-Os™ Sinus Dilation System is an instrument intended to provide a means to access the sinus space and to dilate the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.
    Device Description
    The Vent-OsTM Sinus Dilation System is an osmotically driven device that dilates maxillary sinus ostia and associated spaces. The Vent-Os™ Sinus Dilation System is comprised of a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os™ Sinus Dilation Device then expands and remodels the target tissues and then is removed.
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