Data / Medical devices / France / Vygon S A
Vygon S A: FDA-registered device maker in ECOUEN 95440 Val-d'Oise, France, 42 510(k) clearances
Vygon S A is registered with the FDA (registration 8020785) in ECOUEN 95440 Val-d'Oise, France. It lists 32 device types. The FDA files 42 510(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
- 8020785
- FEI number
- 3009291251
- Address
- 5-11 Rue Adeline, ECOUEN 95440 Val-d'Oise, France, --
- Owner or operator
- VYGON S A (8020785)
- Roles
- Contract sterilizer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- February 14, 1997
- Registered through
- 2026
- Brand names listed
- 121, 122, 1361, 1361.xxx, 1362, 1362.1071, 1362.1072, 1362.1271 and more
Devices it lists
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 |
| March 22, 2017 | K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT | PNR | Substantially Equivalent | Pentaferte Italia S.R.L. | accessdata.fda.gov |
| February 9, 2016 | K151237 | Nutrisafe 2- ENFit Adaptor | PIO | Substantially Equivalent | Vygon | accessdata.fda.gov |
| December 11, 2013 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | Substantially Equivalent | Perouse Medical | accessdata.fda.gov |
| December 18, 2012 | K121105 | NUTRISAFE 2 FEEDING TUBE | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 2, 2012 | K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER | FPA | Substantially Equivalent | Perouse Medical | accessdata.fda.gov |
| October 13, 2011 | K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| November 30, 2007 | K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | FOZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| October 5, 2007 | K063631 | POLYPERF / POLYPERF SAFE | FPA | Substantially Equivalent | Laboratoires Perouse | accessdata.fda.gov |
| September 15, 2006 | K060944 | NUTRISAFE 2 | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| March 2, 2006 | K052881 | VYGON LATEX FREE BIONECTOR | FOZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| June 10, 2004 | K040657 | BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 | BTR | Substantially Equivalent | Vygon SA | accessdata.fda.gov |
| January 21, 2003 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | Substantially Equivalent | Vygon SA | accessdata.fda.gov |
| January 11, 2002 | K003311 | NUTRISAFE PUR ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| October 29, 1999 | K991918 | NUTRISAFE EXTENSION TUBE | KNT | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| October 1, 1998 | K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | FOS | Substantially Equivalent | Schiff & Co. | accessdata.fda.gov |
| March 23, 1998 | K974806 | VYGON NEO-SUMP | KNT | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 9, 1997 | K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| June 2, 1997 | K963571 | VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR | FMI | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 22, 1996 | K960795 | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| June 26, 1995 | K941678 | BIONECTOR | 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 |
| May 20, 1991 | K910909 | MUCAID | BSY | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 20, 1991 | K910908 | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING | BSY | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 29, 1988 | K883612 | LECTROSPIRAL | FPA | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| February 11, 1986 | K860285 | XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE | KNT | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| July 15, 1985 | K851473 | VYGON DELEE SUCTION CATHETER CODE NO 533 | BSY | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 21, 1985 | K851005 | XRO UMBILICAL CATHETER-CODE 270 | FOS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 7, 1985 | K851478 | VYGON SPINAL ANESTHESIA NEEDLE W/INTRODUCER 183 | BSP | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| May 3, 1985 | K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | BRZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| January 30, 1984 | K832628 | VYGON THORACIC DRAINAGE-VARIOUS #'S | KDD | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| July 7, 1983 | K831801 | HEMOCLAV VENOUS CATHETER | FIQ | Substantially Equivalent | Exo, Inc. | accessdata.fda.gov |
| November 16, 1982 | K822879 | ENTERAL NUTRITION 1 | KNT | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| March 18, 1982 | K813360 | DERMAFILE (CAT. # 38 | KKX | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| February 5, 1982 | K820176 | VYGON ENTERNAL NUTRITION TUBES | KNT | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1981 | K813144 | INTRAFLON, INTRAFLUX, INTRAVALVE | DQR | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1981 | K813143 | DESILET | DYB | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1981 | K813142 | LEADER-CATH | DQO | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1981 | K813141 | VYGON STOPCOCKS & RAMPS(MANIFOLDS) | DTL | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
| November 27, 1981 | K813140 | VYGON EXTENSION TUBES & CONNECTORS | DQO | Substantially Equivalent | Exco, Inc. | accessdata.fda.gov |
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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.