Data / Medical devices / France / Sipv
Sipv: FDA-registered device maker in Ecouen Ile-de-France, France, 11 510(k) clearances
Sipv is registered with the FDA (registration 3009291251) in Ecouen Ile-de-France, France. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 18, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009291251
- Address
- 5 Rue Adeline, Ecouen Ile-de-France, France, 95440
- Owner or operator
- VYGON S A (8020785)
- Roles
- Manufacturer
- First device listed
- October 5, 2005
- Registered through
- 2026
- Brand names listed
- 1361, 1362, 1362.1071, 1362.1072, 1362.1271, 1362.1272, 1362.1471, 1362.1671 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Umbilical Artery | FOS | 2 | Manufacturer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | 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 18, 2012 | K121105 | NUTRISAFE 2 FEEDING TUBE | 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 |
| September 15, 2006 | K060944 | NUTRISAFE 2 | FPD | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| January 21, 2003 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | Substantially Equivalent | Vygon SA | accessdata.fda.gov |
| October 1, 1998 | K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | FOS | Substantially Equivalent | Schiff & Co. | 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 |
| February 5, 1982 | K820176 | VYGON ENTERNAL NUTRITION TUBES | KNT | 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 |
Compare with other makers
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Umbilical Artery
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Connector, Airway (Extension)
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Updated December 18, 2012. 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.