Vygon Ams-500
Vygon Ams-500 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K013949 on 27 Mar 2002 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 08498840001318), 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 | Number08498840001318 | Date5 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013949 | Date27 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 08498840001318
- FDA 510(k) database K013949
Across registries
- FDA 510(k) K013949 decided 27 Mar 2002 Active
- FDA GUDID UDI-DI 08498840001318 listed 5 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K013949
- Listed FDA GUDID 08498840001318
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vygon
- Generic name
- Intravenous administration tubing extension set
- Model / Ref / Catalog
- AMS-500
- Primary DI / UDI-DI
- 08498840001318
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Intravenous administration tubing extension set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
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