FDA.reportPublic FDA data

Vygon MFG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12230041000120555Vygon MFG1N2026-01-0187 Venture Dr DOVER NH US 03820

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
832151903883627K963981VYGON BIONECTOR WITH EXTENSION SETFPA1997-02-14
832151577722295K954302VYGON PREMI-CATH - LONG TERM CATHETERLJS1996-06-17
832151177594369K902482VITALMIX (SET & BAG)LHI1990-07-02
832152032504157K896333CMS IV FILTERSFPB1990-01-11
832151929710773K894954.22 & 1.2 MICRON IV FILTERSFPB1989-11-13
832151079995687K884370CMS IV EXTENSION SETSFPK1988-11-07
832151706223075K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKSFPA1988-08-25
832151206883023K873957NON-CORING HUBER TYPE NEEDLESFMI1987-10-23
832151436071345K212370Leaderflex Mini and Leaderflex NanoFOZ2022-08-29
832151400711621K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterPND2018-11-02
832151473195786K172899Vygon PICCsLJS2018-02-26
832151428486809K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerDYB2016-07-05
832151066182931K141026LEADERFLEXFOZ2014-07-30
832151973407761K122834POLYSITE IMPLANTABLE INFUSION PORTSLJT2013-12-11
832151581420357K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
832151628240378K070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039FOZ2007-11-30
832151157631453K062425LIFECATH S PICC AND MIDLINE CATHETERLJS2006-09-15
832151868006499K060944NUTRISAFE 2FPD2006-09-15
832151336099723K053049ALARIS SAFETY MALE LUERFPA2006-01-12
832151287779773K052475VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERSLJS2006-09-14
832151570555402K051690VYGON NUTRILINE CATHETERSLJS2005-08-19
832151575531662K041468PREMICATH, 1261.205LJS2004-09-09
832151219458690K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERKPE2004-12-21
832152035063565K031923ULTRASITE VALVEFPA2003-08-11
832151409469268K030135SAFETY INTRODUCER NEEDLEDYB2003-07-15
832151496873710K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
832151029025386K021395MODIFICATION TO 30 EXTENSION SETFPA2002-05-13
832151202621180K020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GAFPA2002-03-12
832151975301856K013950VENTED VIAL ACCESS DEVICEFPA2002-01-10
832151665828510K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORFPA2002-03-27
832151317575625K013884BOUSSIGNAC C.P.A.P. DEVICEBYE2003-01-21
832151884463835K013871LIFEGUARD SAFETY INFUSION SETFPA2002-03-29
832151669909898K012157CHURCHILL MEDICAL SYSTEMS STOPCOCKFMG2001-09-11
832151568858933K011888PRESSURE ACTIVATED CHECK VALVEFPA2001-09-10
832151899706451K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCKFPA2001-06-12
832151029469488K010913VYGON SPLIT CANNULA INTRODUCERDYB2001-09-28
832151022057925
832151037188799
832151074160994
832151109918483
832151175971994
832151215403011
832151239140145
832151246226938
832151334842286
832151431976237
832151454155353
832151474470939
832151514570710
832151518751556
832151558198271
832151579152364
832151721063546
832151829885880
832151911392558
832151996025286
832152017516678
832152041438949

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA112006-01-12
LJS62018-02-26
DYB42016-07-05
FOZ32022-08-29
FPB21990-01-11
PND12018-11-02
LJT12013-12-11
FPD12006-09-15
KPE12004-12-21
BYE12003-01-21
DQX12002-07-18
FMG12001-09-11
LHI11990-07-02
FPK11988-11-07
FMI11987-10-23