Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5740](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5740) → CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) # CBI · Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) _Anesthesiology · 21 CFR 868.5740 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI ## Overview - **Product Code:** CBI - **Device Name:** Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) - **Regulation:** [21 CFR 868.5740](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5740) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K251950.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K253096.md) | Chartis Precision Catheter | Pulmonx Corporation | Feb 13, 2026 | SESE | | [K232529](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K232529.md) | Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. | May 13, 2024 | SESE | | [K232580](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K232580.md) | Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. | Dec 14, 2023 | SESE | | [K222340](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K222340.md) | Chartis Precision Catheter | Pulmonx Corporation | Dec 1, 2022 | SESE | | [K201026](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K201026.md) | sOLVe Tube | Hytek Medical, Inc. | Aug 10, 2021 | SESE | | [K203749](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K203749.md) | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | Ambu A/S | May 3, 2021 | SESE | | [K200968](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K200968.md) | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | Insung Medical Co., Ltd. | Dec 28, 2020 | SESE | | [K181886](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K181886.md) | VivaSight-DL System | Etview , Ltd. | Nov 14, 2018 | SESE | | [K180253](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K180253.md) | Sheridan Endobronchial Tubes | Teleflex Medical | Nov 2, 2018 | SESE | | [K160542](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K160542.md) | 5.0 Fr Arndt Endobronchial Blocker Set | Cook Incorporated | Aug 2, 2016 | SESE | | [K152251](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K152251.md) | Endobronchial Tube | Henan Tuoren Medical Device Co., Ltd. | Jun 10, 2016 | SESE | | [K141888](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K141888.md) | RUSCH ENDOBRONCHIAL TUBES | Teleflexmedical, Inc. | Apr 15, 2015 | SESE | | [K123853](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K123853.md) | VIVASIGHT-DL SYSTEM | Etview , Ltd. | Apr 15, 2013 | SESE | | [K121462](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K121462.md) | EZ-BLOCKER | Ez-Blocker B.V. | Sep 28, 2012 | SESE | | [K120334](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K120334.md) | VIVA EB | Etview , Ltd. | Jun 8, 2012 | SESE | | [K113576](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K113576.md) | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | Etview , Ltd. | May 18, 2012 | SESE | | [K111522](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K111522.md) | CHARTIS CATHETER MODEL CHR-CA-12.0 | Pulmonx, Inc. | Sep 29, 2011 | SESE | | [K093888](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K093888.md) | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | Daiken Medical Co, Ltd. | Mar 16, 2010 | SESE | | [K092886](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI/K092886.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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