Product code CBI
- Device name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5740
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobr... | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | 2026-02-13 |
| K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 |
| K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | 2023-12-14 |
| K222340 | Chartis Precision Catheter | Pulmonx Corporation | 2022-12-01 |
| K201026 | sOLVe Tube | Hytek Medical, Inc. | 2021-08-10 |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | 2021-05-03 |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | 2020-12-28 |
| K181886 | VivaSight-DL System | Etview , Ltd. | 2018-11-14 |
| K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | 2018-11-02 |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | 2016-08-02 |
| K152251 | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | 2016-06-10 |
| K141888 | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | 2015-04-15 |
| K123853 | VIVASIGHT-DL SYSTEM | Etview , Ltd. | 2013-04-15 |
| K121462 | EZ-BLOCKER | Ez-Blocker B.V. | 2012-09-28 |
| K120334 | VIVA EB | Etview , Ltd. | 2012-06-08 |
| K113576 | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | Etview , Ltd. | 2012-05-18 |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | Pulmonx, Inc. | 2011-09-29 |
| K093888 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | Daiken Medical Co, Ltd. | 2010-03-16 |
| K092886 | WELL LEAD ENDOBRONCHIAL TUBES | Well Lead Instruments | 2010-03-11 |
| K083883 | CHARTIS CATHETER | Pulmonx, Inc. | 2009-06-25 |
| K071694 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX | Daiken Medical Co, Ltd. | 2008-03-20 |
| K051522 | SILBRONCHO DOUBLE LUMEN TUBE | Fuji Systems Corp. | 2005-08-17 |
| K021920 | 7.0 FR. ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2002-08-14 |
| K013865 | TIP DEFLRCTING ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2002-04-22 |
| K010596 | RUSCH BRONCHUS BLOCKER KIT | Rusch Intl. | 2001-11-21 |
| K002288 | ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER | Cook, Inc. | 2000-11-28 |
| K962167 | BRONCHIAL BLOCKER | Cook, Inc. | 1997-08-29 |
| K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-07-31 |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | Smiths Industries Medical Systems, Inc. | 1995-10-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10801902142372 | RUSCH | TELEFLEX INCORPORATED | 2019-03-01 |
| 10749065861504 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065861467 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065861320 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065861382 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065861405 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065861443 | Parker Flex-Tip | SALTER LABS | 2017-08-30 |
| 10749065851383 | Parker Flex-Tip | SALTER LABS | 2017-01-02 |
| 10749065851406 | Parker Flex-Tip | SALTER LABS | 2017-01-02 |
| 10749065851444 | Parker Flex-Tip | SALTER LABS | 2017-01-02 |
| 10749065851468 | Parker Flex-Tip | SALTER LABS | 2017-01-02 |
| 10749065851505 | Parker Flex-Tip | SALTER LABS | 2017-01-02 |
| 10749065061447 | Parker Flex-Tip | SALTER LABS | 2016-01-31 |
| 10749065061461 | Parker Flex-Tip | SALTER LABS | 2016-01-31 |
| 10749065061386 | Parker Flex-Tip | SALTER LABS | 2016-01-31 |
| 10749065061508 | Parker Flex-Tip | SALTER LABS | 2016-01-31 |
| 14026704344335 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344328 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344311 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344304 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344298 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344281 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344274 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344267 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344250 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344243 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344236 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344229 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344212 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 14026704344205 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |