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VYGON Germany GmbH: FDA-registered device maker in AACHEN North Rhine-Westphalia, Germany, 13 510(k) clearances

Name: VYGON Germany GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

VYGON Germany GmbH is registered with the FDA (registration 9612433) in AACHEN North Rhine-Westphalia, Germany. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 30, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9612433
FEI number: 3002808464
Address: Prager Ring 100, AACHEN North Rhine-Westphalia, Germany, D52070
Owner or operator: VYGON S A (8020785)
Roles: Manufacturer, Reprocessor
First device listed: February 2, 2008
Registered through: 2026
Brand names listed: 916402, 9168.202, Double Taper Connector, Epicutaneo-Cava Catheter, Leader-flex, Leaderflex, Lifecath, Lifevac and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Reprocessor	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 30, 2014	K141026	LEADERFLEX	FOZ	Substantially Equivalent	Vygon	accessdata.fda.gov
September 29, 2006	K061250	MULTICATH EXPERT	FOZ	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
September 14, 2006	K052475	VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS	LJS	Substantially Equivalent	Vygon Us, LLC	accessdata.fda.gov
April 5, 2006	K052564	VYGON LEADER-FLEX	FOZ	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
August 19, 2005	K051690	VYGON NUTRILINE CATHETERS	LJS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
September 9, 2004	K041468	PREMICATH, 1261.205	LJS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
September 28, 2001	K010913	VYGON SPLIT CANNULA INTRODUCER	DYB	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
August 3, 2000	K993442	VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)	LJS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
August 3, 2000	K993052	VYGON 2 FR EPICUTANEO PUR-CATHETER	LJS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
June 17, 1996	K954302	VYGON PREMI-CATH - LONG TERM CATHETER	LJS	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
May 9, 1996	K954112	VYGON LIFEVAC MID-LINE TRAY	FOZ	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
August 10, 1990	K901640	MULTICATH PLACEMENT KIT	FOZ	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
April 23, 1990	K897168	EPICUTANEO-CAVA CATHETER CODE 2184	LJS	Unknown	Vygon Corp.	accessdata.fda.gov

Compare with other makers

Updated July 30, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.