VivaSight-EB EBB09700
VivaSight-EB EBB09700 is a Class II device made by E.T. View Ltd, cleared under FDA 510(k) K120334 on 8 Jun 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290013745514), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290013745514 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120334 | Date8 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 07290013745514
- FDA 510(k) database K120334
Across registries
- FDA 510(k) K120334 decided 8 Jun 2012 Active
- FDA GUDID UDI-DI 07290013745514 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120334
- Listed FDA GUDID 07290013745514
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VivaSight-EB
- Generic name
- Bronchial balloon catheter
- Model / Ref / Catalog
- EBB09700
- Primary DI / UDI-DI
- 07290013745514
- 510(k) Number
- FDA product code
- CBI
- GMDN term
- Bronchial balloon catheter
- Device class
- Class II
- Regulation number
- 868.5740
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).
- ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R by INSUNG MEDICAL Co., Ltd..
- Silbroncho Double Lumen Tube by Fuji Systems Corp.
- Solve Tube by Hytek Medical, Inc.
- Laser Resistant Tracheal Tube by Sheridan Catheter Corp.
- Tracheal/Bronchial Differential Ventilation Tube by Sheridan Catheter Corp.
- Univent Tube 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM by Vitaid, Ltd.
- VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000 by Ambu A/S
- Cohen G44122 C-AEBTS-9.0-65-SPH-AS by COOK INCORPORATED
- CHARTIS CATHETER by Pulmonx Corporation
- VivaSight™ 2 DLT Kit 41 Fr - LEFT 412411000 by Ambu A/S