CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Class II
FDA product code CBI covers "Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)", a Class II medical device regulated under 21 CFR 868.5740. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CBI
- Device Class
- Class II
- Regulation Number
- 868.5740
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251950 | hangzhou tappa medical technology co | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endo | March 20, 2026 |
| K253096 | pulmonx corporation | Chartis Precision Catheter | February 13, 2026 |
| K232529 | shenzhen insighters medical technology co | Disposable Double Lumen Endobronchial Tube | May 13, 2024 |
| K232580 | shenzhen insighters medical technology co | Disposable Endobronchial Blocker Tube | December 14, 2023 |
| K222340 | pulmonx corporation | Chartis Precision Catheter | December 1, 2022 |
| K201026 | hytek medical | sOLVe Tube | August 10, 2021 |
| K203749 | ambu | Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable | May 3, 2021 |
| K200968 | insung medical co | ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R | December 28, 2020 |
| K181886 | etview | VivaSight-DL System | November 14, 2018 |
| K180253 | teleflex medical | Sheridan Endobronchial Tubes | November 2, 2018 |
| K160542 | cook incorporated | 5.0 Fr Arndt Endobronchial Blocker Set | August 2, 2016 |
| K152251 | henan tuoren medical device co | Endobronchial Tube | June 10, 2016 |
| K141888 | teleflexmedical | RUSCH ENDOBRONCHIAL TUBES | April 15, 2015 |
| K123853 | etview | VIVASIGHT-DL SYSTEM | April 15, 2013 |
| K121462 | ez-blocker | EZ-BLOCKER | September 28, 2012 |
| K120334 | etview | VIVA EB | June 8, 2012 |
| K113576 | etview | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM | May 18, 2012 |
| K111522 | pulmonx | CHARTIS CATHETER MODEL CHR-CA-12.0 | September 29, 2011 |
| K093888 | daiken medical co | COOPDECH ENDOBRONCHIAL BLOCKER TUBE | March 16, 2010 |
| K092886 | well lead instruments | WELL LEAD ENDOBRONCHIAL TUBES | March 11, 2010 |