510(k) Report

Devices descending from K013266

16 later devices reach Rusch Polyflex Stent Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc.20096—
+1K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc.200811—
+1K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc.200714—
+1K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+2K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20211—
+2K140382Aeromini Tracheobronchial Stent TechnologyMerit Medical Systems, Inc.20141—
+2K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+2K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+2K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+3K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+3K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20220—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+3K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.20180—
+3K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+4K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+5K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—