Panels › Anesthesiology › Product code CBI · Class 2
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Regulation 868.5740
2510(k)s in 12 months (34 all time)
0recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in CBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Medical | 1 | 7 |
| Cook Incorporated | 5 | 0 |
| Etview , Ltd. | 4 | 0 |
| Pulmonx Corporation | 4 | 0 |
| Ambu Inc. | 0 | 2 |
| Daiken Medical Co, Ltd. | 2 | 0 |
| Shenzhen Insighters Medical Technology Co., Ltd. | 2 | 0 |
| Sheridan Catheter Corp. | 2 | 0 |
| Ambu A/S | 1 | 0 |
| Ez-Blocker B.V. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2026 | K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobr Hangzhou Tappa Medical Technology Co., Ltd., CN | CBI |
| Feb 13, 2026 | K253096 | Chartis Precision Catheter Pulmonx Corporation | CBI |
| May 13, 2024 | K232529 | Disposable Double Lumen Endobronchial Tube Shenzhen Insighters Medical Technology Co., Ltd., CN | CBI |
| Dec 14, 2023 | K232580 | Disposable Endobronchial Blocker Tube Shenzhen Insighters Medical Technology Co., Ltd., CN | CBI |
| Dec 1, 2022 | K222340 | Chartis Precision Catheter Pulmonx Corporation | CBI |
| Aug 10, 2021 | K201026 | sOLVe Tube Hytek Medical, Inc. | CBI |
| May 3, 2021 | K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable Ambu A/S, DK | CBI |
| Dec 28, 2020 | K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R Insung Medical Co., Ltd., KR | CBI |
| Nov 14, 2018 | K181886 | VivaSight-DL System Etview , Ltd., IL | CBI |
| Nov 2, 2018 | K180253 | Sheridan Endobronchial Tubes Teleflex Medical | CBI |
| Aug 2, 2016 | K160542 | 5.0 Fr Arndt Endobronchial Blocker Set Cook Incorporated | CBI |
| Jun 10, 2016 | K152251 | Endobronchial Tube Henan Tuoren Medical Device Co., Ltd., CN | CBI |
| Apr 15, 2015 | K141888 | RUSCH ENDOBRONCHIAL TUBES Teleflexmedical, Inc. | CBI |
| Apr 15, 2013 | K123853 | VIVASIGHT-DL SYSTEM Etview , Ltd., IL | CBI |
| Sep 28, 2012 | K121462 | EZ-BLOCKER Ez-Blocker B.V. | CBI |
| Jun 8, 2012 | K120334 | VIVA EB Etview , Ltd., IL | CBI |
| May 18, 2012 | K113576 | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM Etview , Ltd., IL | CBI |
| Sep 29, 2011 | K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 Pulmonx, Inc. | CBI |
| Mar 16, 2010 | K093888 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE Daiken Medical Co, Ltd., JP | CBI |
| Mar 11, 2010 | K092886 | WELL LEAD ENDOBRONCHIAL TUBES Well Lead Instruments | CBI |
| Jun 25, 2009 | K083883 | CHARTIS CATHETER Pulmonx, Inc. | CBI |
| Mar 20, 2008 | K071694 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX Daiken Medical Co, Ltd., JP | CBI |
| Aug 17, 2005 | K051522 | SILBRONCHO DOUBLE LUMEN TUBE Fuji Systems Corp. | CBI |
| Aug 14, 2002 | K021920 | 7.0 FR. ENDOBRONCHIAL BLOCKER Cook, Inc. | CBI |
| Apr 22, 2002 | K013865 | TIP DEFLRCTING ENDOBRONCHIAL BLOCKER Cook, Inc. | CBI |
| Nov 21, 2001 | K010596 | RUSCH BRONCHUS BLOCKER KIT Rusch Intl. | CBI |
| Nov 28, 2000 | K002288 | ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER Cook, Inc. | CBI |
| Aug 29, 1997 | K962167 | BRONCHIAL BLOCKER Cook, Inc. | CBI |
| Jul 31, 1996 | K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE Kendall Healthcare Products Co. Div.Of Tyco Health | CBI |
| Oct 24, 1995 | K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE Smiths Industries Medical Systems, Inc. | CBI |
| Mar 26, 1993 | K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE Sorin Biomedica, Fiat, USA, Inc. | CBI |
| Mar 23, 1990 | K897046 | LASER RESISTANT TRACHEAL TUBE Sheridan Catheter Corp. | CBI |
| Sep 29, 1989 | K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM Vitaid, Ltd., CA | CBI |
| May 23, 1985 | K851856 | TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE Sheridan Catheter Corp. | CBI |
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