CBI
- Product code
- CBI
- Device name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5740
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251950 | 2026-03-20 | Hangzhou Tappa Medical Technology Co., | Endobronchial Blocker Tube (EBT0109); Endobronchial | |
| K253096 | 2026-02-13 | Pulmonx Corporation | Chartis Precision Catheter | |
| K232529 | 2024-05-13 | Shenzhen Insighters Medical Technology | Disposable Double Lumen Endobronchial Tube | |
| K232580 | 2023-12-14 | Shenzhen Insighters Medical Technology | Disposable Endobronchial Blocker Tube |
Official FDA classification page: CBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).