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510(k) Data Aggregation
K Number
K160770Device Name
Vent-Os Sinus Dilation family
Manufacturer
Date Cleared
2016-06-29
(100 days)
Product Code
Regulation Number
874.4420Why 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
K133016Device Name
VENT-OS SINUS DILATION SYSTEM
Manufacturer
Date Cleared
2013-12-09
(75 days)
Product Code
Regulation Number
874.4420Why 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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