BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VYGON USA

    Reg #: 2245270 · FEI: 2245270 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    475
    Establishment Types
    2
    Classifications
    28

    Registration Details

    Registration Name
    VYGON USA
    Registration Number
    2245270
    FEI Number
    2245270
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2750 Morris Rd Suite A200
    City
    Lansdale
    State
    PA
    ZIP
    19446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070705

    Owner / Operator

    Firm Name
    VYGON USA
    Operator Number
    2245270
    Address
    2750 Morris Road, Suite A200
    City
    Lansdale
    State
    PA
    Postal Code
    19446
    Country
    US
    Correspondent
    Chris Steinke

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Stopcock, I.V. Set FMG
    Intravenous Extension Tubing Set OJA
    Introducer, Catheter DYB
    Percutaneous Atrial Catheter Kit OFK
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Gastrointestinal (And Accessories) KNT
    Tube, Feeding FPD
    Port Introducer Kit OKE
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Tubing, Fluid Delivery FPK
    Set, Administration, Intravascular FPA
    Arterial Blood Sampling Kit CBT
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Filter, Infusion Line FPB
    Bone Marrow Biopsy Tray PXO
    Midline Catheter PND
    Dressing Change Tray OXQ
    Scissors, Medical, Disposable JOK
    Peripheral Catheter Insertion Kit OWL
    I.V. Start Kit LRS
    Catheter Introducer Kit OFC
    Wire, Guide, Catheter DQX
    Kit, Surgical Instrument, Disposable KDD
    Suture Kit OVN
    Set, I.V. Fluid Transfer LHI
    Nerve Block Tray OGJ

    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 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-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-140 AMS-2000 AMS-1200LRM AMS-656 AMS-8133 AMS-8475 AMS-635CV-1 AMS-635 PPS-2275 PPS-2210 PPS-2075 PPS-2010 AMS-8307-1 AMS-8368 Lifecath 2296.XXX VYLFN1002 VYLFM1004 VYLFM1003 VYLFN1004 VYLFM1002 VYLFN1003 Leaderflex VYLF Vitalmix Bag Nerve Block Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)