CBI · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Anesthesiology · 21 CFR 868.5740 · Class 2
Overview
| Product Code | CBI |
|---|---|
| Device Name | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Regulation | 21 CFR 868.5740 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) | Hangzhou Tappa Medical Technology Co., Ltd. | Mar 20, 2026 | SESE |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | Feb 13, 2026 | SESE |
| K232529 | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | May 13, 2024 | SESE |
| K232580 | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | Dec 14, 2023 | SESE |
| K222340 | Chartis Precision Catheter | Pulmonx Corporation | Dec 1, 2022 | SESE |
| K201026 | sOLVe Tube | Hytek Medical, Inc. | Aug 10, 2021 | SESE |
| K203749 | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | May 3, 2021 | SESE |
| K200968 | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | Dec 28, 2020 | SESE |
| K181886 | VivaSight-DL System | Etview , Ltd. | Nov 14, 2018 | SESE |
| K180253 | Sheridan Endobronchial Tubes | Teleflex Medical | Nov 2, 2018 | SESE |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | Aug 2, 2016 | SESE |
| K152251 | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | Jun 10, 2016 | SESE |
| K141888 | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | Apr 15, 2015 | SESE |
| K123853 | VIVASIGHT-DL SYSTEM | Etview , Ltd. | Apr 15, 2013 | SESE |
| K121462 | EZ-BLOCKER | Ez-Blocker B.V. | Sep 28, 2012 | SESE |
| K120334 | VIVA EB | Etview , Ltd. | Jun 8, 2012 | SESE |
| K113576 | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | Etview , Ltd. | May 18, 2012 | SESE |
| K111522 | CHARTIS CATHETER MODEL CHR-CA-12.0 | Pulmonx, Inc. | Sep 29, 2011 | SESE |
| K093888 | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | Daiken Medical Co, Ltd. | Mar 16, 2010 | SESE |
| K092886 | WELL LEAD ENDOBRONCHIAL TUBES | Well Lead Instruments | Mar 11, 2010 | SESE |
Top Applicants
- Cook, Inc. — 4 clearances
- Etview , Ltd. — 4 clearances
- Daiken Medical Co, Ltd. — 2 clearances
- Pulmonx Corporation — 2 clearances
- Pulmonx, Inc. — 2 clearances
