510(k) Report

Devices descending from K003173

22 later devices reach Aspire Covered Stent and Delivery Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+1K032744Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.20030—
+1K031641Vascular Architects Aspire Covered Stent and 718 Delivery SystemVascular Architects, Inc.20030—
+1K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200318—
+1K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc.200121—
+2K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc.200714—
+2K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+2K030567Modification to Vascular Architects Aspire Covered Stent and Contrilled Expansion…Vascular Architects, Inc.20031—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc.200811—
+4K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20211—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K140382Aeromini Tracheobronchial Stent TechnologyMerit Medical Systems, Inc.20141—
+4K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+4K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+4K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc.20096—
+5K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+5K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20220—
+5K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.20180—
+5K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+6K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+7K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—