Data / Medical devices / United States / Vygon Usa
Vygon Usa: FDA-registered device maker in Lansdale, PA, United States, 38 510(k) clearances
Vygon Usa is registered with the FDA (registration 2245270) in Lansdale, PA, United States. It lists 28 device types. The FDA files 38 510(k) clearances under its listings, the newest dated August 29, 2022. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2245270
- Address
- 2750 Morris Rd Suite A200, Lansdale, PA, United States, 19446
- Owner or operator
- VYGON USA (2245270)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- January 29, 2008
- Registered through
- 2026
- Brand names listed
- 1015.XXX, 1022.XXX, 2296.XXX, 368.42R, 375141, 375179, 375182, 375185 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 |
| August 27, 2021 | K210047 | Stiletto Extended Dwell Catheter | PND | Substantially Equivalent | Piper Access, LLC | 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 |
| November 18, 2010 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | FPA | Substantially Equivalent | Dragon Heart Medical, Inc. | 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 |
| October 5, 2007 | K063631 | POLYPERF / POLYPERF SAFE | FPA | Substantially Equivalent | Laboratoires Perouse | 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 |
| March 2, 2006 | K052881 | VYGON LATEX FREE BIONECTOR | FOZ | Substantially Equivalent | Vygon Corp. | 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 |
| 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 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 |
| September 9, 1997 | K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | 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 |
| 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 |
|---|---|---|---|---|---|---|
| April 15, 2021 | 87802 | Class II | Ongoing | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection | accessdata.fda.gov |
| December 6, 2018 | 81866 | Class II | Terminated | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. | DualStop Caps defect causing leaks in affected product | accessdata.fda.gov |
| February 28, 2018 | 79752 | Class II | Terminated | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. | Potential friction holes may affect the sterility of the product. | accessdata.fda.gov |
| August 28, 2014 | 69204 | Class II | Terminated | 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 medications to patients | Vygon has uncovered potential problems with membrane elasticity in the, Bionector Needleless connector and is issuing a voluntary recall of the, Bionector Needleless connector. | accessdata.fda.gov |
| December 17, 2012 | 64458 | Class II | Terminated | 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. | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. | accessdata.fda.gov |
| May 11, 2012 | 61945 | Class II | Terminated | 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 | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. | accessdata.fda.gov |
| April 26, 2011 | 58810 | Not yet classified | Terminated | LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter | Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration. | accessdata.fda.gov |
| April 19, 2011 | 58794 | Not yet classified | Terminated | Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit. | Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. | accessdata.fda.gov |
| June 27, 2005 | 32997 | Not yet classified | Terminated | Premicath 28G PICC Catheter | Guidewire protuding from tip of the catheter | accessdata.fda.gov |
| April 9, 2003 | 26213 | Not yet classified | Terminated | 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. Sterilization occurs via Et | Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath. | accessdata.fda.gov |
Compare with other makers
- All makers of Nerve Block Tray
- All makers of Set, Administration, Intravascular
- All makers of Dressing Change Tray
- All makers of Arterial Blood Sampling Kit
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of Stopcock, I.V. Set
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.