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relieva spinplus rsp0616mfs gudid 20705031232386 relieva spinplus balloon sinuplasty system, 6x16 3 guide kit acclarent, inc. fda.report ›

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The Balloon Sinuplasty System is intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

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12. Acclarent is a medical device company that sells balloon sinuplasty devices. ... system/relieva-spinplus-balloon-sinuplasty-system). I (available. at.

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Jul 30, 2019 · TruDi Navigation System, a real-time, 3D image-guided navigation system designed for ENT (ear, nose, throat) procedures. TruDi is designed specifically for intranasal and paranasal image-guided navigation procedures, though it also enables the use of the RELIEVA Spinplus Nav 3D navigation-enabled balloon sinuplasty system for treating chronic ...

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(Relieva SpinPlus Nav ™ Balloon Sinuplasty System) Subject Device NAV Wire) The RELIEVA SPINPLUS ™ Nav Balloon Sinuplasty System may be utilized in conjunction with the ACCLARENT ® ENT Navigation System, to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. Single-Use . Yes Yes Yes . Sterile ...

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Step 4: Remove System The irrigation catheter is removed, leaving the ostium open and the sinus cleared of mucus allowing the re-turn of sinus drainage. There is little to no disruption to mucosal lining. Relieva Balloon Sinuplasty™ Technology Relieva Balloon Sinuplasty™ Devices Shaping the Future of ENT Care™ Step 1: Gain Access to the Sinus

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Nov 16, 2019 · The company offers RELIEVA SCOUT Multi-Sinus Dilation System, RELIEVA SPINPLUS Balloon Sinuplasty System, and RELIEVA ULTIRRA Sinus Balloon Catheter. Medtronic.

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Oct 12, 2020 · Advancing or retracting the Sinus Balloon Catheter while the Sinus Balloon is inflated may cause damage to the RELIEVA SPINPLUS. The ACCLARENT AERA™ system uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain … ACCLARENT® Balloon Sinuplasty Device use has described risks, including ...

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Apr 01, 2015 · FDA 510(k) Decisions During April, 2015 FDA 510(k) Number: Decision Date: Device Name: Applicant: Contact: K142745: 04/01/2015

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cdm code,cdm description,price 1,price 2,comment,,,,, 0164450112,als 1 emergent," 2,310.00 ",,,,, 0164450232,als 1 emergent >1 person," 2,310.00 ",,,,, 0164450113,als ...
Relieva Spin Balloon Sinuplasty System Sinus Guide Catheter Tip Diameter 6 mm x Length 16 mm Tip Shape F Tip Angle Ref RS0616F These item have a Use by date of either ...
Feb 14, 2020 · Relieva SpinPlus Balloon Sinuplasty System Acclarent Inc. K143541 4/22/2015 Sinus Ostia Dilation XprESS Multi-Sinus Dilation Tool Entellus Medical Inc. K142252 10/17/2014 Sinus Ostia Dilation Relieva Scout Multi-Sinus Dilation System Acclarent Inc. K140160 2/20/2014 Sinus Ostia Dilation
cdm code,cdm description,price 1,price 2,comment,,,,, 0164450112,als 1 emergent," 2,310.00 ",,,,, 0164450232,als 1 emergent >1 person," 2,310.00 ",,,,, 0164450113,als ...
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RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and According to the manufacturer, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and ...