510(k) Report

Devices descending from K043527

55 later devices reach Relieva Sinus Balloon Dilation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+1K073041Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc.200818—
+1K061903Relieva Sinus Balloon CatheterAcclarent, Inc.200649—
+1K052198Relieva Sinus Balloon Inflation DeviceAcclarent, Inc.20056—
+2K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+2K150172ACCLARENT SE Inflation DeviceAcclarent, Inc.20150—
+2K111875Relieva Spin Sinus Dilation SystemAcclarent, Inc.20117—
+2K111254Relieva Solo Elite Sinus Balloon CatheterAcclarent, Inc.20117—
+2K102366Finess EndoscopeEntellus Medical, Inc.20110—
+2K093007Entellus Medical Balloon DeviceEntellus Medical, Inc.201041—
+2K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.200947
+2K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+2K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC20080—
+3K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd.20230—
+3K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+3K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+3K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+3K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC20160—
+3K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+3K150951aeris Balloon Dialation CatheterBryan Medical, Inc.201511
+3K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+3K133016Vent-OS Sinus Dilation SystemSinusys Corporation20130—
+3K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+3K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+3K110218Inspira Air Balloon Dilation SystemAcclarent, Inc.201109
+3K102003Xpress Balloon DeviceEntellus Medical, Inc.201036—
+4K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+4K181838Sinusway Dilation System3nt Medical, Ltd.20180—
+4K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+4K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+4K132297EM Sinus Dilation SystemMedtronic Xomed, Inc.20135—
+4K121351Sinus Dilation SystemEntrigue Surgical, Inc.20128—
+4K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+4K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201121—
+5K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+5K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+5K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp.20130—
+5K121174Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201220—
+5K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+6K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+6K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+6K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+7K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+7K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+8K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+9K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+10K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+10K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+11K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+11K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+11K201398SINUSPRIME Dilation SystemStryker Ent20200—
+11K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+12K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+12K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+13K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—