Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245270

FEI Number

2245270

Entity Name

VYGON USA

City/State/Country

Lansdale, PA, US

Establishment Address

2750 Morris Rd Suite A200, Lansdale, PA 19446, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

VYGON USA (Owner Number: 2245270)

Owner / Operator Contact Address

2750 Morris Road, Suite A200, Lansdale, PA 19446, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013950

PMA Number

N/A

All Registered Proprietary Names

CMS-8000 bionector AMS-300 AMS-100 AMS-200 BN-3002 AMS-400 Filter and Fluid Connector AMS-539-2 MSPT-010878 AMS-539-3 AMS-8182-1 AMS-537 VYAA AMS-9946CP-6 AMS-9941CP-6 AMS-9941CP-5 AMS-9335CP-2 MSY-2234 MSY-2250 MBS-1910 MSY-1910 MSY-2034 MBS-2234 MSY-2010 MBS-2034 MBS-2010 MBS-2015 MBS-2210 Non-coring Huber Set MBS-2210-1 MSY-2010-1 MSY-2034-1 MBS-2034-1 MSY-2234-1 MBS-2234-1 MBS-2010-1 MBS-2250 MSY-1915 MSY-2210 MSY-2015 Nutrisafe 2 1015.XXX 368.42R 1022.XXX POLYSITE IMPLANTABLE INFUSION PORTS AMS-497 AMS-543 AMS-105-1 AMS-555-1 AMS-385 AMS-285 AMS-755-1 AMS-904 CMS-396 AMS-440 SS-112-1 AMS-629-1 AMS-481 SS-395B AMS-120 AMS-483 AMS-240 AMS-401 KS-332-1 AMS-301 AMS-379-1 AMS-609-1 AMS-674-1 SS-481 AMS-395-1 CMS-814-1 AMS-184-1 SHS-1910 SHY-2210 SHY-2010 SHS-2010 SHS-2250 SHS-2015 SHS-2210 SHY-2250 BHS-2015 BHY-2010 BHS-2250 BHS-2034 BHS-1910 BHS-2210 BHY-1915 BHS-2010 BHY-2210 BHY-2234 BHY-2034 BHY-1910 BHY-2250 BHY-2015 BHS-2234 SHS-2034-1 SHY-2010-1 SHS-2234-1 SHY-2034-1 SHS-2210-1 SHS-2010-1 SHS-2034 SHY-1915 SHS-2234 SHY-2015 SHY-2034 SHY-2234 SHY-1910 CLGY-2234 CLGY-2050 CLG-2210 CLGY-1934 CLG-2015 CLGY-2250 CLGY-2010 LifeGuard CLG-1934-1 CLG-2234-1 CLG-2010-1 CLG-2250-1 CLGY-2034-1 CLGY-2010-1 CLGY-2015-1 CLGY-1910 CLG-1910-1 CLG-2210-1 CLGY-2234-1 CLG-2010 CLGY-2034 CLG-2034 CLG-1910 CLGY-2015 CLG-2250 CLGY-2210 CLG-1934 CLG-2234 CLG-2050 AMS-7086 AMS-7070 AMS-729CP-3 AMS-8165CP-3 AMS-7480CS-2 AMS-9837CP-7 AMS-8165CP-3A AMS-9837CP-6 AMS-7074CP-2A AMS-9161CP AMS-9161CPA AMS-9837CP-7A AMS-7073CP AMS-9788CP-4 AMS-9147CP AMS-2087CP AMS-2008 AMS-9777CP AMS-9140-2 AMS-7074CP-2 Premicath Boussignac CPAP Device 5562.X13 CMS-207 premicath AMS-427 SS-426 AMS-428 AMS-426-1 AMS-900CV IV Extension Sets AMS-500NS AMS-500 Bone Marrow Procedure Tray AMS-9008 AMS-547 Vytaline PICCs VYPL PIP210100 PIP210200 PIP200000 PIP200100 AMS-7000-1 AMS-7870CP-21 AMS-8354CP-3 375185 AMS-8093CP AMS-8405CP-1 AMS-7066CP-1 AMS-9478CP-1 AMS-8142CP-1 AMS-8115CP-2 AMS-8485CP-1 AMS-9860-1 AMS-7079LF AMS-9956CP-8 AMS-7100CS AMS-9817CP-3 AMS-9943CP AMS-9940CP-1 AMS-9591CS AMS-8498CP AMS-9872CP AMS-8502CP-2 AMS-9913CP-2 AMS-8227CP-3 AMS-8738CP-1 AMS-8464CP-5 AMS-9942CP-3 AMS-8240CP-1 AMS-8952CP AMS-9788CP-3 AMS-7200 AMS-9857-6 AMS-938-4 AMS-8464CP-6 AMS-8346 AMS-9067CP AMS-8149-5 AMS-9055CP AMS-9788CP-2 AMS-9478CP AMS-9275CP-2 AMS-7639CP AMS-9942CP-6 AMS-8405CP-3 AMS-8344 AMS-9788CP-3A AMS-8346-1 AMS-8465CS AMS-7870CP-22 AMS-9129CP AMS-9860-2 375182 375186 375141 AMS-7180-3 AMS-8251CP-1 AMS-8109CP-1 AMS-8219 AMS-8526CP AMS-9944-1 AMS-8122CP-2 AMS-8141CP AMS-8460CP-2 AMS-9513CS-1 AMS-9818CP-3 AMS-8471CP-2 AMS-9857-4 AMS-9279 AMS-8149-4 AMS-8508CP AMS-9811CP-4 AMS-8108CP-3 AMS-9958CP AMS-7341CP AMS-8292CP-3 Vytaline Midlines VYML AMS-582 VYG-423-1 AMS-423-1 VIS-1045 VIS-1055 VAT premicath AMS-850TC V-Cutter AMS-923CP AMS-8070CP VY-MAXPRO AMS-8423CP AMS-9868CP-3 AMS-8180-3CP AMS-9377CP-2A AMS-9983CP-1 AMS-6186CP HCT8874VA-VA AMS-8186CP AMS-8198-1 AMS-9140A AMS-9294CS AMS-9437CP-2 AMS-8508CP-2 AMS-9734 AMS-8010CP-1 AMS-8198CS AMS-8054CP AMS-9021CP-1A AMS-9294 AMS-9018CP AMS-9437CP-2A VYMAXBASIC HCT8198-VA AMS-9983CP-1A AMS-8526CP-2 AMS-9849-1 AMS-9152CP-2 AMS-8034CP AMS-9048CP-1 HCT8874VA-V AMS-9140-1 AMS-9038CS-1A AMS-750 AMS-7192CS-3 AMS-9021CP-1 AMS-9868CP-3A AMS-9214CP-1 AMS-9046CP AMS-7058CP AMS-7063-1 AMS-9140 AMS-7072CS AMS-8199 AMS-7192CS-4 AMS-8345CP-1 AMS-9152CP-1 AMS-8126CP-2A AMS-9192CP AMS-7160CPA AMS-7104CP AMS-8023CP-1A AMS-9540CP AMS-9870CP VY-MAX AMS-9983CP-2 VSKTLS-PA AMS-8517CP AMS-7170CP AMS-8126CP-2 AMS-8461CS AMS-7192CS-8 AMS-599 AMS-8181CP VSKTLS-VYC AMS-8062CP AMS-9093CP AMS-6180CP AMS-9152CP nutriline CMS-5000 AMS-9034CS AMS-728CS AMS-865CP AMS-875CS AMS-624TG-6 AMS-712CP-1 AMS-896CP-1 AMS-846CP AMS-813CP AMS-970CP AMS-9501-3 AMS-953CS 375200 AMS-772AT AMS-983CS-2 AMS-712CP AMS-9010CP AMS-921CP 375198 AMS-872CP AMS-987AG-1 AMS-785CP AMS-626TGSLF AMS-804CP AMS-797CS 375201 AMS-759CP-1 AMS-744CP AMS-968CP-1 AMS-957CP AMS-926CPS AMS-623TG-6LF AMS-905CS AMS-793CP-1 AMS-858CP-2 AMS-917CP AMS-823CP AMS-908AT-1 AMS-928CS AMS-834T AMS-769VG-1 375179 AMS-827CP-1 AMS-696 AMS-845CS-1 AMS-804CP-1 AMS-623T-6 AMS-9501-1 AMS-627ATG-5 AMS-912CP-2 AMS-769VG-2 AMS-7517CPA-1 AMS-905CS-1 AMS-872CP-1 AMS-849CP AMS-9983CP-2 AMS-737CP AMS-827CP-2 AMS-859CS-4 AMS-869CP AMS-9049CS VAMST5.5 VAMST4 VAMST3.5 VAMST6 VYG AMS-483C AMS-884-2T AMS-375 CMS-608 AMS-546-2 AMS-944 AMS-540-1 AMS-485-1 AMS-519-1 AMS-542 BN-762 AMS-803 AMS-467 SS-461 AMS-467C AMS-176 AMS-945 AMS-887-4 SS-885-2 KS-122-2 AMS-122-1 AMS-975FO AMS-494 AMS-577-1 AMS-532 SS-933-1 AMS-292-2 KS-975NF-2 BN-160 AMS-541 AMS-975-1 KS-975-2 AMS-975NF AMS-998-1 AMS-295-1 KS-222-2 AMS-934-1 AMS-451 AMS-565 AMS-490 AMS-570 AMS-492 AMS-2001 BN-300 AMS-290 BN-150 BN-160 BN-140 AMS-2000 AMS-1200LRM

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	2009-08-18
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-01-29
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2016-09-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-03-22
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2013-02-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-10-16
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2009-08-18
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2009-08-18
OKE	Port Introducer Kit	General Hospital	Class 2	880.5965	2025-07-29
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-07-29
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-10-16
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	2013-01-23
OKE	Port Introducer Kit	General Hospital	Class 2	880.5965	2013-02-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2015-07-15
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-06-10
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-18
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-06-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29
PXO	Bone Marrow Biopsy Tray	General, Plastic Surgery	Class 1	878.4800	2017-09-01
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2019-02-15
PND	Midline Catheter	General Hospital	Class 2	880.5200	2026-02-04
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2013-01-14
PND	Midline Catheter	General Hospital	Class 2	880.5200	2019-02-15
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2008-01-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-03-22
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2009-08-18
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2011-12-08
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2013-02-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2009-08-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-08-05
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2014-03-07
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2019-12-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-03-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-01-29

Official Correspondent

Chris Steinke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VYGON USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1223004	Vygon MFG	DOVER, NH, US

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
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

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
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

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1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245270. Last updated year: 2026. Please use registration number 2245270 when referencing this establishment in official correspondence.