Data / Medical devices / Portugal / Vygon Portugal
Vygon Portugal: FDA-registered device maker in Balter-Paredes Porto, Portugal, 8 510(k) clearances
Vygon Portugal is registered with the FDA (registration 3014663754) in Balter-Paredes Porto, Portugal. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014663754
- Address
- Parque Empresarial de Baltar/Parada Rua F 7585-013, Balter-Paredes Porto, Portugal, 7585-013
- Owner or operator
- VYGON S A (8020785)
- Roles
- Manufacturer
- First device listed
- January 3, 2008
- Registered through
- 2026
- Brand names listed
- 1361, 1361.xxx, 1362, 1362.xxx, 1363, 1363.xxx, 1364, 1364.xxx and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Umbilical Artery | FOS | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Feeding | FPD | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | K243361 | Nutrifit | FPD | Substantially Equivalent | Vygon USA | accessdata.fda.gov |
| October 13, 2011 | K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 15, 2006 | K060944 | NUTRISAFE 2 | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 9, 1997 | K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 2, 1994 | K925854 | VYGON - ENTERAL FEEDING TUBE - POLYURETHANE | KNT | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| October 26, 1992 | K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | FOS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| October 26, 1992 | K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | FOS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| November 16, 1982 | K822879 | ENTERAL NUTRITION 1 | KNT | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Tube, Feeding
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Umbilical Artery
Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.