CBI

Death

4

Malfunction

594

Total

598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K251950 — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) Hangzhou Tappa Medical Technology Co., Ltd. · 2026-03-20
• K253096 — Chartis Precision Catheter Pulmonx Corporation · 2026-02-13
• K232529 — Disposable Double Lumen Endobronchial Tube Shenzhen Insighters Medical Technology Co., Ltd. · 2024-05-13
• K232580 — Disposable Endobronchial Blocker Tube Shenzhen Insighters Medical Technology Co., Ltd. · 2023-12-14
• K222340 — Chartis Precision Catheter Pulmonx Corporation · 2022-12-01
• K201026 — sOLVe Tube Hytek Medical, Inc. · 2021-08-10
• K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable Ambu A/S · 2021-05-03
• K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R Insung Medical Co., Ltd. · 2020-12-28
• K181886 — VivaSight-DL System Etview , Ltd. · 2018-11-14
• K180253 — Sheridan Endobronchial Tubes Teleflex Medical · 2018-11-02
• K160542 — 5.0 Fr Arndt Endobronchial Blocker Set Cook Incorporated · 2016-08-02
• K152251 — Endobronchial Tube Henan Tuoren Medical Device Co., Ltd. · 2016-06-10
• K141888 — RUSCH ENDOBRONCHIAL TUBES Teleflexmedical, Inc. · 2015-04-15
• K123853 — VIVASIGHT-DL SYSTEM Etview , Ltd. · 2013-04-15
• K121462 — EZ-BLOCKER Ez-Blocker B.V. · 2012-09-28
• K120334 — VIVA EB Etview , Ltd. · 2012-06-08
• K113576 — DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM Etview , Ltd. · 2012-05-18
• K111522 — CHARTIS CATHETER MODEL CHR-CA-12.0 Pulmonx, Inc. · 2011-09-29
• K093888 — COOPDECH ENDOBRONCHIAL BLOCKER TUBE Daiken Medical Co, Ltd. · 2010-03-16
• K092886 — WELL LEAD ENDOBRONCHIAL TUBES Well Lead Instruments · 2010-03-11
• K083883 — CHARTIS CATHETER Pulmonx, Inc. · 2009-06-25
• K071694 — COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX Daiken Medical Co, Ltd. · 2008-03-20
• K051522 — SILBRONCHO DOUBLE LUMEN TUBE Fuji Systems Corp. · 2005-08-17
• K021920 — 7.0 FR. ENDOBRONCHIAL BLOCKER Cook, Inc. · 2002-08-14
• K013865 — TIP DEFLRCTING ENDOBRONCHIAL BLOCKER Cook, Inc. · 2002-04-22
• K010596 — RUSCH BRONCHUS BLOCKER KIT Rusch Intl. · 2001-11-21
• K002288 — ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER Cook, Inc. · 2000-11-28
• K962167 — BRONCHIAL BLOCKER Cook, Inc. · 1997-08-29
• K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE Kendall Healthcare Products Co. Div.Of Tyco Health · 1996-07-31
• K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE Smiths Industries Medical Systems, Inc. · 1995-10-24
• K925615 — SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE Sorin Biomedica, Fiat, USA, Inc. · 1993-03-26
• K897046 — LASER RESISTANT TRACHEAL TUBE Sheridan Catheter Corp. · 1990-03-23
• K894337 — UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM Vitaid, Ltd. · 1989-09-29
• K851856 — TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE Sheridan Catheter Corp. · 1985-05-23