510(k) Report

Devices descending from K894380

22 later devices reach Dumon Tracheobronchial Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971509EndoxaneNovatech SA199721—
+2K243126Tracheobronxane™ Dumon®Novatech SA20240—
+2K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.20210—
+2K182743Patient-Specific Airway StentNew Cos, Inc.20192—
+2K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc.200811—
+2K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc.200714—
+2K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+3K261541VisionAir Enhanced Stock StentVisionAir Solutions20260—
+3K213969VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions20220—
+3K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20211—
+3K140382Aeromini Tracheobronchial Stent TechnologyMerit Medical Systems, Inc.20141—
+3K140472Bonastent Tracheal / BronchialEndochoice, Inc.20141—
+3K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation201411
+3K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+3K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc.20096—
+4K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+4K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20220—
+4K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+4K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.20180—
+4K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+5K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+6K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—