Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612433

FEI Number

3002808464

Entity Name

VYGON Germany GmbH

City/State/Country

AACHEN North Rhine-Westphalia, DE

Establishment Address

PRAGER RING 100, AACHEN North Rhine-Westphalia D52070, DE

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

K051690

PMA Number

N/A

All Registered Proprietary Names

PUR Epicutaneo-Cave Catheter Leader-flex Vygon Measuring Tape Multicath Epicutaneo-Cava Catheter Premicath Vygocard 2 916402 9168.202 Vygon Split Cannula Introducer Twinflo Nutriline Double Taper Connector Multicath Expert Nutriline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2012-04-20
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
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2013-06-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-02-02
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2008-02-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2015-02-26
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

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
3002808467	Dimequip	Frameries Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612433. Last updated year: 2026. Please use registration number 9612433 when referencing this establishment in official correspondence.