Vygon Corp.
Medical device manufacturer in Lansdale Montgomery, PA.
53510(k) clearances
0PMA approvals
20recalls
Device types
- LJS Catheter, Intravascular, Therapeutic… 11
- FOZ Catheter, Intravascular, Therapeutic… 9
- FPD Tube, Feeding 4
- KNT Tubes, Gastrointestinal (And Accessories) 4
- FOS Catheter, Umbilical Artery 3
- BSY Catheters, Suction, Tracheobronchial 3
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 2
- DYB Introducer, Catheter 2
- FPA Set, Administration, Intravascular 2
- BTR Tube, Tracheal (W/Wo Connector) 2
- PIO Enteral Specific Transition Connectors 1
- GBX Catheter, Irrigation 1
- BYE Attachment, Breathing, Positive End… 1
- FMI Needle, Hypodermic, Single Lumen 1
- LFJ Catheter, Subclavian 1
- DQY Catheter, Percutaneous 1
- CAZ Anesthesia Conduction Kit 1
- LAE High Pressure Liquid Chromatography, Codeine 1
- BSP Needle, Conduction, Anesthetic (W/Wo… 1
- LAZ N-Acetylprocainamide Control Materials 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241587 | pilot TLSLJS · Traditional | 02/26/2025SE |
| K151237 | Nutrisafe 2- ENFit AdaptorPIO · Traditional | 02/09/2016SE |
| K141026 | LeaderflexFOZ · Traditional | 07/30/2014SE |
| K121105 | Nutrisafe 2 Feeding TubeFPD · Traditional | 12/18/2012SE |
| K100163 | Nutrisafe 2 Feeding Tubes Model 362.XXX. 1362.XXXFPD · Traditional | 10/13/2011SE |
| K073493 | Hepatostat SetGAM · Traditional | 05/06/2008SE |
| K070705 | Modification to: Latex-Free Bionector, Model# 896.019, 896.039FOZ · Traditional | 11/30/2007SE |
| K061796 | Hepatostat Set, Model 760XGAM · Traditional | 11/02/2006SE |
| K061250 | Multicath ExpertFOZ · Traditional | 09/29/2006SE |
| K062425 | Lifecath S Picc and Midline CatheterLJS · Special | 09/15/2006SE |
| K060944 | Nutrisafe 2FPD · Special | 09/15/2006SE |
| K052564 | Vygon Leader-FlexFOZ · Traditional | 04/05/2006SE |
| K052881 | Vygon Latex Free BionectorFOZ · Traditional | 03/02/2006SE |
| K051248 | Vygon Micro-Access Safety Introducer KitDYB · Traditional | 10/27/2005SE |
| K051690 | Vygon Nutriline CathetersLJS · Traditional | 08/19/2005SE |
| K041468 | Premicath, 1261.205LJS · Traditional | 09/09/2004SE |
| K040657 | Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80BTR · Traditional | 06/10/2004SE |
| K013884 | Boussignac C.P.A.P. DeviceBYE · Traditional | 01/21/2003SE |
| K003311 | Nutrisafe Pur Enteral Feeding TubeFPD · Traditional | 01/11/2002SE |
| K010913 | Vygon Split Cannula IntroducerDYB · Traditional | 09/28/2001SE |
| K993442 | Vygon Lifecath-Picc (Pur) Catheters (Single and Double Lumen 3FR, 4FR, 4.5FR, and 5FR)LJS · Traditional | 08/03/2000SE |
| K993052 | Vygon 2 FR Epicutaneo Pur-CatheterLJS · Traditional | 08/03/2000SE |
| K991918 | Nutrisafe Extension TubeKNT · Traditional | 10/29/1999SE |
| K983544 | Vygon Double Lumen Picc-Catheters (4FR. and 5FR.)LJS · Traditional | 01/13/1999SE |
| K974806 | Vygon Neo-SumpKNT · Traditional | 03/23/1998SE |
| K963196 | Vygon Umbilical Cathether Insertion TrayFOZ · Traditional | 09/09/1997SE |
| K963571 | Vygon Multi-Dose Vial Adapter & BionectorFMI · Traditional | 06/02/1997SE |
| K963981 | Vygon Bionector with Extension SetFPA · Traditional | 02/14/1997SE |
| K954302 | Vygon Premi-Cath - Long Term CatheterLJS · Traditional | 06/17/1996SE |
| K960795 | Vygon Double Lumen Endotracheal TubeBTR · Traditional | 05/22/1996SE |
| K954112 | Vygon Lifevac Mid-Line TrayFOZ · Traditional | 05/09/1996SE |
| K954638 | 5 FR Picc-Line CatheterLJS · Traditional | 04/22/1996SE |
| K941678 | BionectorFOZ · Traditional | 06/26/1995SE |
| K925854 | Vygon - Enteral Feeding Tube - PolyurethaneKNT · Traditional | 05/02/1994SE |
| K921374 | Vygon Xro Venous/Arterial Umbilical CatheterFOS · Traditional | 10/26/1992SE |
| K921352 | Vygon Polyurethane Venous/Arterial Xro Umbil. CathFOS · Traditional | 10/26/1992SE |
| K910909 | MucaidBSY · Traditional | 05/20/1991SE |
| K910908 | Mucaid with Suction Catheter and Extension TubingBSY · Traditional | 05/20/1991SE |
| K903648 | Vygon Lifevac PiccLJS · Traditional | 03/07/1991SEKD |
| K901640 | Multicath Placement KitFOZ · Traditional | 08/10/1990SE |
| K896568 | Dualyse-Cath - Codes #1132.212, 1132.112LFJ · Traditional | 05/09/1990SE |
| K897168 | Epicutaneo-Cava Catheter Code 2184LJS · Traditional | 04/23/1990SEKD |
| K883612 | LectrospiralFPA · Traditional | 09/29/1988SE |
| K870067 | Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20DQY · Traditional | 04/28/1987SE |
| K860285 | Xro Gastro-Duodenal, Dual Flow Tube, Salem TypeKNT · Traditional | 02/11/1986SE |
| K851473 | Vygon Delee Suction Catheter Code No 533BSY · Traditional | 07/15/1985SE |
| K851479 | Vygon Balloon for Identification of Epidural 193CAZ · Traditional | 06/14/1985SE |
| K851005 | Xro Umbilical Catheter-Code 270FOS · Traditional | 05/21/1985SE |
| K851480 | Vygon Guedel Airway 511 Vygon Bermann/Orophar AirwLAE · Traditional | 05/07/1985SE |
| K851478 | Vygon Spinal Anesthesia Needle W/Introducer 183BSP · Traditional | 05/07/1985SE |
| K851474 | Vygon Spinal Anesthesia Tray Code No. 190LAZ · Traditional | 05/07/1985SE |
| K851477 | Vygon Exchange Transfusion Tray 275.00BRZ · Traditional | 05/03/1985SE |
| K851475 | Vygon Cannula for Surgical Suction Yan Kauer 574/5GBX · Traditional | 05/03/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0113-2015 Class II | Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a…Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless… | 08/28/2014Terminated |
| Z-0937-2013 Class II | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple…Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is… | 12/17/2012Terminated |
| Z-1808-2012 Class II | Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1807-2012 Class II | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1806-2012 Class II | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1805-2012 Class II | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1804-2012 Class II | Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1803-2012 Class II | Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1802-2012 Class II | Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1801-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1800-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1799-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1798-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-1797-2012 Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush…Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore… | 05/11/2012Terminated |
| Z-2700-2011 | LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product…Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which… | 04/26/2011Terminated |
| Z-2699-2011 | LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product…Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which… | 04/26/2011Terminated |
| Z-2391-2011 | Churchill Medical Systems AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | 04/19/2011Terminated |
| Z-2390-2011 | Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | 04/19/2011Terminated |
| Z-2389-2011 | Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | 04/19/2011Terminated |
| Z-2388-2011 | Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a…Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion… | 04/19/2011Terminated |