FDA.reportPublic FDA data

VYGON USA

Matched from indexed company URL: Vygon USA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22452702245270VYGON USA1Y2026-01-012750 Morris Rd Suite A200 Lansdale PA US 19446

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
364962037311133K963196VYGON UMBILICAL CATHETHER INSERTION TRAYFOZ1997-09-09
364961577722295K954302VYGON PREMI-CATH - LONG TERM CATHETERLJS1996-06-17
364961177594369K902482VITALMIX (SET & BAG)LHI1990-07-02
364962032504157K896333CMS IV FILTERSFPB1990-01-11
364961929710773K894954.22 & 1.2 MICRON IV FILTERSFPB1989-11-13
364961706223075K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKSFPA1988-08-25
364961206883023K873957NON-CORING HUBER TYPE NEEDLESFMI1987-10-23
364961436071345K212370Leaderflex Mini and Leaderflex NanoFOZ2022-08-29
364961935866264K210047Stiletto Extended Dwell CatheterPND2021-08-27
364961400711621K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterPND2018-11-02
364961473195786K172899Vygon PICCsLJS2018-02-26
364961428486809K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerDYB2016-07-05
364961066182931K141026LEADERFLEXFOZ2014-07-30
364961973407761K122834POLYSITE IMPLANTABLE INFUSION PORTSLJT2013-12-11
364961499095673K101368D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIESFPA2010-11-18
364961581420357K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
364961628240378K070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039FOZ2007-11-30
364961246226938K063631POLYPERF / POLYPERF SAFEFPA2007-10-05
364961157631453K062425LIFECATH S PICC AND MIDLINE CATHETERLJS2006-09-15
364961868006499K060944NUTRISAFE 2FPD2006-09-15
364961336099723K053049ALARIS SAFETY MALE LUERFPA2006-01-12
364961612860544K052881VYGON LATEX FREE BIONECTORFOZ2006-03-02
364961287779773K052475VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERSLJS2006-09-14
364961570555402K051690VYGON NUTRILINE CATHETERSLJS2005-08-19
364961575531662K041468PREMICATH, 1261.205LJS2004-09-09
364962035063565K031923ULTRASITE VALVEFPA2003-08-11
364961409469268K030135SAFETY INTRODUCER NEEDLEDYB2003-07-15
364961496873710K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
364961029025386K021395MODIFICATION TO 30 EXTENSION SETFPA2002-05-13
364961202621180K020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GAFPA2002-03-12
364961975301856K013950VENTED VIAL ACCESS DEVICEFPA2002-01-10
364961665828510K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORFPA2002-03-27
364961317575625K013884BOUSSIGNAC C.P.A.P. DEVICEBYE2003-01-21
364961884463835K013871LIFEGUARD SAFETY INFUSION SETFPA2002-03-29
364961669909898K012157CHURCHILL MEDICAL SYSTEMS STOPCOCKFMG2001-09-11
364961568858933K011888PRESSURE ACTIVATED CHECK VALVEFPA2001-09-10
364961899706451K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCKFPA2001-06-12
364961022057925
364961037188799
364961074160994
364961079995687
364961239140145
364961334842286
364961431976237
364961558198271
364961579152364
364961829885880
364961911392558
364961996025286
364962017516678
364962041438949

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA122010-11-18
LJS62018-02-26
FOZ52022-08-29
DYB32016-07-05
PND22021-08-27
FPB21990-01-11
LJT12013-12-11
FPD12006-09-15
BYE12003-01-21
DQX12002-07-18
FMG12001-09-11
LHI11990-07-02
FMI11987-10-23

PMN#