Data / Medical devices / United States / Vygon MFG
Vygon MFG: FDA-registered device maker in Dover, NH, United States, 37 510(k) clearances
Vygon MFG is registered with the FDA (registration 1223004) in Dover, NH, United States. It lists 35 device types. The FDA files 37 510(k) clearances under its listings, the newest dated August 29, 2022. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1223004
- FEI number
- 1000120555
- Address
- 87 Venture Dr, Dover, NH, United States, 03820
- Owner or operator
- VYGON USA (2245270)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 9, 2005
- Registered through
- 2026
- Brand names listed
- 1015.XXX, 1022.XXX, 1262.30N, 2296.XXX, 368.42R, 375141, 375179, 375182 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 29, 2022 | K212370 | Leaderflex Mini and Leaderflex Nano | FOZ | Substantially Equivalent | Vygon USA | accessdata.fda.gov |
| November 2, 2018 | K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | PND | Substantially Equivalent | Vygon USA | accessdata.fda.gov |
| February 26, 2018 | K172899 | Vygon PICCs | LJS | Substantially Equivalent | Vygon USA | accessdata.fda.gov |
| July 5, 2016 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| July 30, 2014 | K141026 | LEADERFLEX | FOZ | Substantially Equivalent | Vygon | accessdata.fda.gov |
| December 11, 2013 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | Substantially Equivalent | Perouse Medical | accessdata.fda.gov |
| May 2, 2012 | K120261 | PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER | FPA | Substantially Equivalent | Perouse Medical | accessdata.fda.gov |
| December 8, 2008 | K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| November 30, 2007 | K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | FOZ | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 15, 2006 | K062425 | LIFECATH S PICC AND MIDLINE CATHETER | LJS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 15, 2006 | K060944 | NUTRISAFE 2 | FPD | 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 |
| January 12, 2006 | K053049 | ALARIS SAFETY MALE LUER | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 19, 2005 | K051690 | VYGON NUTRILINE CATHETERS | LJS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| December 21, 2004 | K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | KPE | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| September 9, 2004 | K041468 | PREMICATH, 1261.205 | LJS | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| August 11, 2003 | K031923 | ULTRASITE VALVE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 15, 2003 | K030135 | SAFETY INTRODUCER NEEDLE | DYB | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 21, 2003 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | Substantially Equivalent | Vygon SA | accessdata.fda.gov |
| July 18, 2002 | K021990 | GALT MEDICAL GUIDEWIRE | DQX | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| May 13, 2002 | K021395 | MODIFICATION TO 30 EXTENSION SET | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| March 29, 2002 | K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | Substantially Equivalent | Horizon Medical Products, Inc. | accessdata.fda.gov |
| March 27, 2002 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| March 12, 2002 | K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| January 10, 2002 | K013950 | VENTED VIAL ACCESS DEVICE | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| September 28, 2001 | K010913 | VYGON SPLIT CANNULA INTRODUCER | DYB | Substantially Equivalent | Vygon Corp. | accessdata.fda.gov |
| September 11, 2001 | K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | FMG | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| September 10, 2001 | K011888 | PRESSURE ACTIVATED CHECK VALVE | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| June 12, 2001 | K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| February 14, 1997 | K963981 | VYGON BIONECTOR WITH EXTENSION SET | FPA | 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 |
| July 2, 1990 | K902482 | VITALMIX (SET & BAG) | LHI | Substantially Equivalent | Pacific Device, Inc. | accessdata.fda.gov |
| January 11, 1990 | K896333 | CMS IV FILTERS | FPB | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| November 13, 1989 | K894954 | .22 & 1.2 MICRON IV FILTERS | FPB | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| November 7, 1988 | K884370 | CMS IV EXTENSION SETS | FPK | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| August 25, 1988 | K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS | FPA | Substantially Equivalent | Churchill Medical Systems, Inc. | accessdata.fda.gov |
| October 23, 1987 | K873957 | NON-CORING HUBER TYPE NEEDLES | FMI | Substantially Equivalent | Advantage Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2019 | 84010 | Class II | Terminated | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray. | accessdata.fda.gov |
| October 3, 2017 | 79318 | Class II | Terminated | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency. | The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled. | accessdata.fda.gov |
| July 24, 2017 | 78951 | Class II | Terminated | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the | accessdata.fda.gov |
| February 20, 2017 | 76607 | Class II | Terminated | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids. | Incorrect priming volume printed on the device package. | accessdata.fda.gov |
| November 18, 2016 | 75816 | Class II | Terminated | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids. | Incorrect priming volume is printed on the device package. | accessdata.fda.gov |
| January 15, 2015 | 70369 | Class II | Terminated | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids | Potential for leaking caused by insufficient bond between needleless device and female luer. | accessdata.fda.gov |
| January 7, 2014 | 67255 | Class II | Terminated | AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set. | Defective component may cause extension sets to leak. | accessdata.fda.gov |
| August 12, 2013 | 66060 | Class II | Terminated | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. | Microbore tubing disconnecting from male luers on the extension sets. | accessdata.fda.gov |
| January 21, 2013 | 64464 | Class II | Terminated | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports. | The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. | accessdata.fda.gov |
| April 16, 2012 | 61653 | Not yet classified | Terminated | Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports. | Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set,; however, the product label states 20Ga MBS-2010 code listed on device label. | accessdata.fda.gov |
| July 15, 2011 | 59466 | Not yet classified | Terminated | Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressin | Outer Kit labeled expiration date longer than the expiration of the shortest expired product | accessdata.fda.gov |
| November 16, 2010 | 57295 | Not yet classified | Terminated | WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W Intended use: Intravascular Administration Set | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. | accessdata.fda.gov |
| January 29, 2010 | 54481 | Not yet classified | Terminated | Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vygon/Churchill Medical System | Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml. | accessdata.fda.gov |
| October 20, 2009 | 54174 | Not yet classified | Terminated | Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration s | Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents | accessdata.fda.gov |
Compare with other makers
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- All makers of Percutaneous Atrial Catheter Kit
Updated August 29, 2022. 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.