Company · US

Vygon Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2025. Name variants (Inc, Corp, punctuation) are merged.

57510(k) clearances (0 in 12 months)

34recalls (0 in 12 months)

19recalls that name a 510(k)

Product codes

Code	Device	Records
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	16
NZW	Heparin, Vascular Access Flush	12
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	11
OWL	Peripheral Catheter Insertion Kit	8
FPD	Tube, Feeding	5
FPA	Set, Administration, Intravascular	4
KNT	Tubes, Gastrointestinal (And Accessories)	4
LKB	Pad, Alcohol, Device Disinfectant	4
BSY	Catheters, Suction, Tracheobronchial	3
FOS	Catheter, Umbilical Artery	3
BTR	Tube, Tracheal (W/Wo Connector)	2
DQO	Catheter, Intravascular, Diagnostic	2
DYB	Introducer, Catheter	2
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	2
BRZ	Set, Blood Transfusion	1
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	1
BYE	Attachment, Breathing, Positive End Expiratory Pressure	1
CAZ	Anesthesia Conduction Kit	1
DQY	Catheter, Percutaneous	1
FMI	Needle, Hypodermic, Single Lumen	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Feb 26, 2025	K241587	pilot TLS Vygon Corporation	LJS
Dec 19, 2024	K243361	Nutrifit Vygon USA	FPD
Aug 29, 2022	K212370	Leaderflex Mini and Leaderflex Nano Vygon USA	FOZ
Nov 2, 2018	K181208	Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Vygon USA	PND
Feb 26, 2018	K172899	Vygon PICCs Vygon USA	LJS
Feb 9, 2016	K151237	Nutrisafe 2- ENFit Adaptor Vygon	PIO
Jul 30, 2014	K141026	LEADERFLEX Vygon	FOZ
Dec 18, 2012	K121105	NUTRISAFE 2 FEEDING TUBE Vygon Corp.	FPD
Oct 13, 2011	K100163	NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX Vygon Corp.	FPD
May 6, 2008	K073493	HEPATOSTAT SET Vygon Corp.	GAM
Nov 30, 2007	K070705	MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 Vygon Corp.	FOZ
Nov 2, 2006	K061796	HEPATOSTAT SET, MODEL 760X Vygon Corp.	GAM
Sep 29, 2006	K061250	MULTICATH EXPERT Vygon Corp.	FOZ
Sep 15, 2006	K062425	LIFECATH S PICC AND MIDLINE CATHETER Vygon Corp.	LJS
Sep 15, 2006	K060944	NUTRISAFE 2 Vygon Corp.	FPD
Apr 5, 2006	K052564	VYGON LEADER-FLEX Vygon Corp.	FOZ
Mar 2, 2006	K052881	VYGON LATEX FREE BIONECTOR Vygon Corp.	FOZ
Oct 27, 2005	K051248	VYGON MICRO-ACCESS SAFETY INTRODUCER KIT Vygon Corp.	DYB
Aug 19, 2005	K051690	VYGON NUTRILINE CATHETERS Vygon Corp.	LJS
Sep 9, 2004	K041468	PREMICATH, 1261.205 Vygon Corp.	LJS
Jun 10, 2004	K040657	BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 Vygon SA	BTR
Jan 21, 2003	K013884	BOUSSIGNAC C.P.A.P. DEVICE Vygon SA	BYE
Jan 11, 2002	K003311	NUTRISAFE PUR ENTERAL FEEDING TUBE Vygon Corp.	FPD
Sep 28, 2001	K010913	VYGON SPLIT CANNULA INTRODUCER Vygon Corp.	DYB
Aug 3, 2000	K993442	VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) Vygon Corp.	LJS
Aug 3, 2000	K993052	VYGON 2 FR EPICUTANEO PUR-CATHETER Vygon Corp.	LJS
Oct 29, 1999	K991918	NUTRISAFE EXTENSION TUBE Vygon Corp.	KNT
Jan 13, 1999	K983544	VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) Vygon Corp.	LJS
Mar 23, 1998	K974806	VYGON NEO-SUMP Vygon Corp.	KNT
Sep 9, 1997	K963196	VYGON UMBILICAL CATHETHER INSERTION TRAY Vygon Corp.	FOZ
Jun 2, 1997	K963571	VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR Vygon Corp.	FMI
Feb 14, 1997	K963981	VYGON BIONECTOR WITH EXTENSION SET Vygon Corp.	FPA
Jun 17, 1996	K954302	VYGON PREMI-CATH - LONG TERM CATHETER Vygon Corp.	LJS
May 22, 1996	K960795	VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE Vygon Corp.	BTR
May 9, 1996	K954112	VYGON LIFEVAC MID-LINE TRAY Vygon Corp.	FOZ
Apr 22, 1996	K954638	5 FR PICC-LINE CATHETER Vygon Corp.	LJS
Jun 26, 1995	K941678	BIONECTOR Vygon Corp.	FOZ
May 2, 1994	K925854	VYGON - ENTERAL FEEDING TUBE - POLYURETHANE Vygon Corp.	KNT
Oct 26, 1992	K921374	VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER Vygon Corp.	FOS
Oct 26, 1992	K921352	VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH Vygon Corp.	FOS
May 20, 1991	K910909	MUCAID Vygon Corp.	BSY
May 20, 1991	K910908	MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING Vygon Corp.	BSY
Mar 7, 1991	K903648	VYGON LIFEVAC PICC Vygon Corp.	LJS
Aug 10, 1990	K901640	MULTICATH PLACEMENT KIT Vygon Corp.	FOZ
May 9, 1990	K896568	DUALYSE-CATH - CODES #1132.212, 1132.112 Vygon Corp.	LFJ
Apr 23, 1990	K897168	EPICUTANEO-CAVA CATHETER CODE 2184 Vygon Corp.	LJS
Sep 29, 1988	K883612	LECTROSPIRAL Vygon Corp.	FPA
Apr 28, 1987	K870067	MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20 Vygon Corp.	DQY
Feb 11, 1986	K860285	XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE Vygon Corp.	KNT
Jul 15, 1985	K851473	VYGON DELEE SUCTION CATHETER CODE NO 533 Vygon Corp.	BSY

Newest 50 of 57.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Apr 15, 2021	Vygon U.S.A. Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. Open, Classified	OXQ	None listed
Dec 6, 2018	Vygon U.S.A. Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines. Terminated	FPA	None listed
Dec 6, 2018	Vygon U.S.A. Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. Terminated	FPA	None listed
Feb 28, 2018	Vygon U.S.A. PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Feb 28, 2018	Vygon U.S.A. PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. Terminated	OWL	None listed
Oct 22, 2014	Vygon Corporation Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medi Terminated	FOZ	K070705
Mar 11, 2013	Vygon Corporation Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. Terminated	LJS	K081904
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter l Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter l Terminated	NZW	K061497
Jun 13, 2012	Vygon Corporation Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens Terminated	NZW	K061497
Jun 29, 2011	Vygon Corporation LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter Terminated	LJS	K062425
Jun 29, 2011	Vygon Corporation LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter Terminated	LJS	K062425
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change K Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a PICC insertion tray. Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing kit. Terminated	LKB	None listed
Jun 11, 2011	Vygon Corporation Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit. Terminated	LKB	None listed
Oct 28, 2005	Vygon Corporation Premicath 28G PICC Catheter Terminated	LJS	K041468
May 20, 2003	Vygon Corporation Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respec Terminated	DQO	K954112
May 20, 2003	Vygon Corporation Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Ster Terminated	DQO	K954112

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