Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014663754

FEI Number

3014663754

Entity Name

Vygon Portugal

City/State/Country

Balter-Paredes Porto, PT

Establishment Address

Parque Empresarial de Baltar/Parada, Rua F 7585-013, Balter-Paredes Porto 7585-013, PT

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

Expiration Date (Year)

2026

510(k) Number

K243361

PMA Number

N/A

All Registered Proprietary Names

PUR Umbilical Catheter PVC Enteral Feeding Tubes Nutrisafe 2 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 PVC XRO Venous/Arterial Umbilical Catheter Vygon XRO PVC Venous/Arterial Umbilical Catheter 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2012-03-26
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	2008-02-02
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2012-03-26
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

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
9612433	VYGON Germany GmbH	AACHEN North Rhine-Westphalia, DE
3002808467	Dimequip	Frameries Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014663754. Last updated year: 2026. Please use registration number 3014663754 when referencing this establishment in official correspondence.