Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808466

FEI Number

3002808466

Entity Name

SIPA

City/State/Country

Avesnes Sur Helpe Hauts-de-France, FR

Establishment Address

22 Avenue Stroh, Avesnes Sur Helpe Hauts-de-France 59440, 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

K040657

PMA Number

N/A

All Registered Proprietary Names

Thoracic trocar and drain Vygon XRO PVC Venous/Arterial Umbilical Catheter Vyclic Vygon Spinal Anesthesia Needle w/ Introducer Boussignac

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-08-31
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2012-03-26
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-03-26
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2008-02-02
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-01-03

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
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
K963972	Klein-Baker Medical, Inc.	NEO-CARE DUAL LUMEN UMBILICAL CATHETER	1996-12-24
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808466. Last updated year: 2026. Please use registration number 3002808466 when referencing this establishment in official correspondence.