VivaSight-EB EBB09700AS
VivaSight-EB EBB09700AS 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 21 Feb 2018 (UDI-DI 07290013745804), 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 | Number07290013745804 | Date21 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120334 | Date8 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 07290013745804
- FDA 510(k) database K120334
Across registries
- FDA 510(k) K120334 decided 8 Jun 2012 Active
- FDA GUDID UDI-DI 07290013745804 listed 21 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K120334
- Listed FDA GUDID 07290013745804
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- Withdrawn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
- EBB09700AS
- Primary DI / UDI-DI
- 07290013745804
- 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
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