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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