510(k) Report

Devices descending from K963241

35 later devices reach Ultraflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp20125—
+1K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc.200811—
+1K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc.200714—
+1K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+1K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200415—
+1K032744Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.20030—
+1K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc.200318—
+1K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp20012146
+1K990221Intracoil Peripheral StentIntratherapeutics, Inc.19991—
+2K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation20230—
+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
+2K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation20132—
+2K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102—
+2K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc.20096—
+2K072094ChoostentM.I.Tech Co., Ltd.20085—
+2K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815—
+2K021563Intracoil Self-Expanding Peripheral StentSulzer Intratherapeutics, Inc.20020—
+3K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific2024122
+3K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20220—
+3K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212—
+3K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.20200—
+3K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20190—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183—
+3K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.20180—
+3K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd.20100—
+3K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914—
+4K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation20260—
+4K233837Agile Esophageal Stent SystemBoston Scientific Corporation202419
+4K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.20183—
+5K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.20212—
+6K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.20250—
+6K213251HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd.20210—