FDA 510(k) Applications for Medical Device Product Code "CBI"
(Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K203749 | Ambu A/S | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | 05/03/2021 |
| K160542 | COOK INCORPORATED | 5.0 Fr Arndt Endobronchial Blocker Set | 08/02/2016 |
| K021920 | COOK, INC. | 7.0 FR. ENDOBRONCHIAL BLOCKER | 08/14/2002 |
| K002288 | COOK, INC. | ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER | 11/28/2000 |
| K962167 | COOK, INC. | BRONCHIAL BLOCKER | 08/29/1997 |
| K013865 | COOK, INC. | TIP DEFLRCTING ENDOBRONCHIAL BLOCKER | 04/22/2002 |
| K093888 | DAIKEN MEDICAL CO, LTD. | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | 03/16/2010 |
| K071694 | DAIKEN MEDICAL CO, LTD. | COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX | 03/20/2008 |
| K113576 | ETVIEW LTD. | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | 05/18/2012 |
| K120334 | ETVIEW LTD. | VIVA EB | 06/08/2012 |
| K123853 | ETVIEW LTD. | VIVASIGHT-DL SYSTEM | 04/15/2013 |
| K181886 | ETView Ltd. | VivaSight-DL System | 11/14/2018 |
| K121462 | EZ-BLOCKER B.V. | EZ-BLOCKER | 09/28/2012 |
| K051522 | FUJI SYSTEMS CORP. | SILBRONCHO DOUBLE LUMEN TUBE | 08/17/2005 |
| K152251 | HENAN TUOREN MEDICAL DEVICE CO., LTD | Endobronchial Tube | 06/10/2016 |
| K201026 | HyTek Medical, Inc. | sOLVe Tube | 08/10/2021 |
| K200968 | INSUNG MEDICAL CO., LTD. | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | 12/28/2020 |
| K961977 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE | 07/31/1996 |
| K222340 | Pulmonx Corporation | Chartis Precision Catheter | 12/01/2022 |
| K083883 | PULMONX, INC. | CHARTIS CATHETER | 06/25/2009 |
| K111522 | PULMONX, INC. | CHARTIS CATHETER MODEL CHR-CA-12.0 | 09/29/2011 |
| K010596 | RUSCH INTL. | RUSCH BRONCHUS BLOCKER KIT | 11/21/2001 |
| K232529 | Shenzhen Insighters Medical Technology Co., Ltd. | Disposable Double Lumen Endobronchial Tube | 05/13/2024 |
| K232580 | Shenzhen Insighters Medical Technology Co., Ltd. | Disposable Endobronchial Blocker Tube | 12/14/2023 |
| K180253 | Teleflex Medical | Sheridan Endobronchial Tubes | 11/02/2018 |
| K141888 | Teleflex Medical, Inc. | RUSCH ENDOBRONCHIAL TUBES | 04/15/2015 |
| K092886 | WELL LEAD INSTRUMENTS | WELL LEAD ENDOBRONCHIAL TUBES | 03/11/2010 |
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