510(k) Report

Devices descending from K894337

15 later devices reach Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0219207.0 FR. Endobronchial BlockerCook, Inc.200214—
+2K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107)…Hangzhou Tappa Medical Technology Co., Ltd.20260—
+2K121462EZ-BlockerEz-Blocker B.V.20120—
+2K120334Viva EBEtview, Ltd.20120—
+2K083883Chartis CatheterPulmonx, Inc.20093—
+2K071694Coopdech Endobronchial Blocker Tube, Models BBT-A30XXX, BBT-B30XXXDaiken Medical Co, Ltd.20088—
+3K111522Chartis Catheter Model CHR-CA-12.0Pulmonx, Inc.20112—
+3K093888Coopdech Endobronchial Blocker TubeDaiken Medical Co, Ltd.20106—
+4K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.20230—
+4K222340Chartis Precision CatheterPulmonx Corporation20221—
+4K121028Etview Tracheoscopic Ventilation Tube (TVT (TM))Etview, Ltd.20123—
+5K253096Chartis Precision CatheterPulmonx Corporation20260—
+5K181880VivaSight-SL (TVT) systemEtview, Ltd.20180—
+5K152438ETView VivaSight-SL (TVT) systemEtview, Ltd.20161—
+6K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…Flexicare Medical Limited.20250—