VivaSight Pack TVEB75105
VivaSight Pack TVEB75105 is a Class II device made by E.T. View Ltd, cleared under FDA 510(k) K152438 on 25 Feb 2016 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290013745552), 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 | Number07290013745552 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152438 | Date25 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 07290013745552
- FDA 510(k) database K152438
- FDA 510(k) database K120334
Across registries
- FDA 510(k) K152438 decided 25 Feb 2016 Active
- FDA GUDID UDI-DI 07290013745552 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120334
- Cleared FDA 510(k) K152438
- Listed FDA GUDID 07290013745552
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VivaSight Pack
- Generic name
- Bronchial balloon catheter
- Model / Ref / Catalog
- TVEB75105
- Primary DI / UDI-DI
- 07290013745552
- FDA product code
- CBI, BTR
- GMDN term
- Bronchial balloon catheter
- Device class
- Class II
- Regulation number
- 868.5740, 868.5730
- GUDID distribution status
- In Commercial Distribution
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