Vygon Shs-2234-1
by Vygon Corp.
Vygon Shs-2234-1 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K020544 on 12 Mar 2002 and listed in FDA GUDID since 28 Jun 2024 (UDI-DI 00849884006438), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00849884006438 | Date28 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020544 | Date12 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 00849884006438
- FDA 510(k) database K020544
Across registries
- FDA 510(k) K020544 decided 12 Mar 2002 Active
- FDA GUDID UDI-DI 00849884006438 listed 28 Jun 2024 Listed
Recalls
-
- Terminated Z-1333-2011
Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
Timeline
- Cleared FDA 510(k) K020544
- Recall initiated FDA recalls Z-1333-2011
- Listed FDA GUDID 00849884006438
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vygon
- Generic name
- Vascular port administration set
- Model / Ref / Catalog
- SHS-2234-1
- Primary DI / UDI-DI
- 00849884006438
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Vascular port administration set
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
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