VYGON S A

FDA Device Registration & Listing · ECOUEN 95440 Val-d'Oise, FR · Registration 8020785

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8020785
FEI Number
3009291251
Entity Name
VYGON S A
City/State/Country
ECOUEN 95440 Val-d'Oise, FR
Establishment Address
5-11 RUE ADELINE, ECOUEN 95440 Val-d'Oise --, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
VYGON S A (Owner Number: 8020785)
Owner / Operator Contact Address
5-11 RUE ADELINE, --, ECOUEN, FR-NOTA 95440, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K851478
PMA Number
N/A

All Registered Proprietary Names

Dermafilm Nutrisafe 2 Vygon PUR Enteral Feeding Tubes Polyperf Nutrifit Enteral Feeding Tube - Closed tip-PUR-1366.Xxx 368.xxxx 1362.xxx 1364.xxx 362.xxx 363.xxx 361.xxx 1363.xxx 1361.xxx 368.xxx 366.xxx 364.xxx 1366.xxx Nutrifit Enteral Feeding Tube-PVC 366.Xxx Intraflon 2 122 121 Latex-Free Bionector Vygon Exchange Transfusion Tray 275.xxx Nasal Oxygen Catheter XRO Gastro-Duodenal Dual Flow Salem Type Feeding Tube Nutrisafe 2 1362871 1362.1271 1362.1671 1366671 1362.1072 1366.1871 1362671 1362.1272 1362.1471 1366871 1366.1271 1366872 1366.1072 1362.1871 1366.1272 1362872 1366.1471 1362.1071 1366.1671 81757 1362 1364 1361 361 364 8187 817.207 82887 1363 817572 NUTRIFIT SAMPLING STRAW 339172 NUTRIFIT 36897 368.47 82817 362 363 817.208 368.1572 817.157 58027 Vygon XRO PVC Venous/Arterial Umbilical Catheter Polysite Vygon Multi-Dose Vial Adaptor and Bionector Nutrifit/ENFit Enteral Syringe with cap -1015.Xxxx Thoracic trocar and drain Vene-K BOUGIE BOUSSIGNAC PPS PI Vygon Double Lumen Endotracheal Tube Grip-Lok Leader-Cath Nutrisafe Silicone Enteral Feeding Tubes Leaderflex PVC Enteral Feeding Tubes Mucaid Vygon NeoSump Gastric Aspirator Nutrisafe 2 PUR Umbilical Catheter Nutrisafe 2 - ENFit Adaptor Lectospiral NeoHelp Hemoclav TRACHEOBRONCHIAL CATHETERS Mucaid Vygon PVC Umbilical Catheter Lectrocath Caps and Connectors Bionector BOUGIE BOUSSIGNAC T Vygon PVC XRO Venous/Arterial Umbilical Catheter FiO2 Adaptor Ring Vygon Spinal Anesthesia Needle w/ Introducer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2012-01-13
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2015-08-31
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-02-02
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-06-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-06-19
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-01-14
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2025-01-14
DQR Cannula, Catheter Cardiovascular Class 2 870.1300 2014-01-24
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2008-01-03
BRZ Set, Blood Transfusion General Hospital Class 2 880.5440 2015-01-08
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2016-05-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-02-02
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2015-08-31
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2008-01-03
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-03
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2012-03-26
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2018-06-19
OKE Port Introducer Kit General Hospital Class 2 880.5965 2018-06-19
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-01-03
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-02-24
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2015-08-31
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2017-12-13
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2007-08-06
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-06-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-06-19
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2012-03-26
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2015-06-10
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-03-26
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-03
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-03-12
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-08-31
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-03-26
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2008-02-02
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-03-12
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2015-08-31
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2008-02-02
PIO Enteral Specific Transition Connectors Gastroenterology, Urology Class 2 876.5980 2016-07-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-02
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2015-01-08
FIQ Cannula, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2016-07-20
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 1997-02-14
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2008-02-02
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-02-02
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2013-03-12
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2008-02-02
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2007-08-06
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-02-02
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2014-08-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2008-02-02

Official Correspondent

Chris Steinke

US Agent Details

Chris Steinke Email: csteinke@vygon.com Phone: (603) 7435988

Related Public Records

Same Entity

VYGON S A
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002808468 SAP Saint Saulve Hauts-de-France, FR
3009291251 SIPV Ecouen Ile-de-France, FR
3002808466 SIPA Avesnes Sur Helpe Hauts-de-France, FR
3014663754 Vygon Portugal Balter-Paredes Porto, PT
9612433 VYGON Germany GmbH AACHEN North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020785. Last updated year: 2026. Please use registration number 8020785 when referencing this establishment in official correspondence.
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