Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009291251

FEI Number

3009291251

Entity Name

SIPV

City/State/Country

Ecouen Ile-de-France, FR

Establishment Address

5 Rue Adeline, Ecouen Ile-de-France 95440, 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

Expiration Date (Year)

2026

510(k) Number

K121105

PMA Number

N/A

All Registered Proprietary Names

PUR Umbilical Catheter Leader-Cath 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 PUR Enteral Feeding Tubes Nutrisafe 2 Silicone Enteral Feeding Tubes 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

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
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-03-26
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
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-02-02
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2015-08-31
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

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
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
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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23

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

Similar Registrations

Registration Number	Establishment Name	Location
2245270	VYGON USA	Lansdale, PA, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG
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 3009291251. Last updated year: 2026. Please use registration number 3009291251 when referencing this establishment in official correspondence.