Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011237770

FEI Number

3011237770

Entity Name

Vygon Verneuil

City/State/Country

Verneuil En Halatte Oise, FR

Establishment Address

Parc Alata, 5 Avenue des Bouleaux, Verneuil En Halatte Oise 60550, FR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

VYGON S A (Owner Number: 8020785)

Owner / Operator Contact Address

5-11 RUE ADELINE, --, ECOUEN, FR-NOTA 95440, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mucaid Hemoclav PVC Enteral Feeding Tubes Desilet Vygon Split Cannula Introducer Dermafilm Vygon Double Lumen Endotracheal Tube Intravascular Extension Set AMS-924C-1 AMS-467 AMS-467C PUR Umbilical Catheter Thoracic trocar and drain Polysite Boussignac Nutrisafe 2 PPS PI Delee Lifevac Intraflon 2 122 121 Premicath Silicone Enteral Feeding Tubes Bionector Lifecath XRO Gastro-Duodenal Dual Flow Salem Type Feeding Tube Multicath Expert Double Taper Connector Nutrisafe Premicath Multicath 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 BOUSSIGNAC C.P.A.P. DEVICE Lectrocath Caps and Connectors PUR Epicutaneo-Cave Catheter Nasal Oxygen Catheter Leaderflex BOUGIE BOUSSIGNAC T Grip-Lok Twinflo Nutriline Vygon NeoSump Gastric Aspirator Nutrisafe 2 - ENFit Adaptor NeoHelp 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 Nutrisafe 2 Vygon XRO PVC Venous/Arterial Umbilical Catheter IMPREGNATED SURGICAL BRUSH FiO2 Adaptor Ring Vygon Exchange Transfusion Tray 275.xxx Polyperf Leader-Cath Vygon PVC XRO Venous/Arterial Umbilical Catheter Epicutaneo-Cava Catheter Vygon Spinal Anesthesia Needle w/ Introducer Vygon PUR Enteral Feeding Tubes Vygocard 2 916402 9168.202

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2008-02-02
FIQ	Cannula, A-V Shunt	Gastroenterology, Urology	Class 2	876.5540	2016-07-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-03-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-07-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-02-02
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2012-01-13
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2012-03-26
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2014-09-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-02
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-08-31
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
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-01-03
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2015-08-31
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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2008-02-02
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-02
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2014-01-24
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
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	2008-02-02
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-02-02
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-02-26
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-03
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-02
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
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2005-10-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-03-12
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2016-05-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-08-31
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2007-08-06
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2015-06-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2013-03-12
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-07-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-01-08
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
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2015-08-31
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2012-03-26
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2006-11-21
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2014-08-18
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2015-01-08
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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-03-26
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2008-02-02
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-02-02
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-02-02
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2013-06-28

Official Correspondent

Chris Steinke

US Agent Details

Chris Steinke Business: Vygon USA 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
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
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011237770. Last updated year: 2026. Please use registration number 3011237770 when referencing this establishment in official correspondence.