510(k) Report

Devices descending from K021920

14 later devices reach 7.0 FR. Endobronchial Blocker through their predicates, nearest generation first.

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