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
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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