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
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
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
K961977 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE 07/31/1996
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
K897046 SHERIDAN CATHETER CORP. LASER RESISTANT TRACHEAL TUBE 03/23/1990
K851856 SHERIDAN CATHETER CORP. TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE 05/23/1985
K953483 SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. SIMS BLUE LINE ENDOBRONCHIAL TUBE 10/24/1995
K925615 SORIN BIOMEDICA, FIAT, USA, INC. SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE 03/26/1993
K141888 Teleflex Medical, Inc. RUSCH ENDOBRONCHIAL TUBES 04/15/2015
K894337 VITAID, LTD. UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM 09/29/1989
K092886 WELL LEAD INSTRUMENTS WELL LEAD ENDOBRONCHIAL TUBES 03/11/2010


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