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Merit Medical UK Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30153096433015309643Merit Medical UK Limited1N2026-01-01Unit 27, Suttons Business Park Sutton Park Avenue Earley Reading GB RG6 1AW

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3323371724216489P240023WRAPSODY® Cell-Impermeable EndoprosthesisPFV2024-12-19
3323371160162634K994253VACLOK SYRINGEFMF2000-01-05
3323371990776746K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-07-23
3323371400122723K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-06-09
3323371383750645K974570PERITONEAL DIALYSIS CATHETER CONNECTORFKO1998-02-27
3323371638338147K974374SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STVJKA1998-01-02
3323371902321357K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEY1998-02-27
3323371161469967K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)DXT1997-11-25
3323371917151923K970159FLEX-NECK PD CATHETERFJS1997-09-05
3323371372009656K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
3323371765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
3323371293310046K941428EXACTA PERCUTANEOUS INTRODUCER SHEATHDYB1994-07-06
3323371750030742K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITKRB1994-03-25
3323371457952433K936032TORQUE DEVICEDQX1994-03-15
3323371890171816K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIESDXN1994-08-01
3323371269848180K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
3323371004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
3323371529948956K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
3323371145189192K920977MERITRANS(TM) DISPOSABLE TRANSDUCERDRS1992-12-11
3323371668957218K915678MERIT ADMINISTRATION SETFPA1992-07-30
3323371641249949K914208MERIT DISPOSAL DEPOT(TM)DQO1991-12-18
3323371847819263K902319BAUER TEMNO BIOPSY NEEDLEFCG1990-09-06
3323371266210610K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.DSK1989-01-25
3323371049947372K883718MERIT HI-FLEX(TM)FPK1989-01-30
3323371034006889K880740MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGEDQF1988-03-22
3323371240318017K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCDXT1988-02-11
3323371370245607K870261VIGGO EXACTA PRESSURE MONITORING SYSTEMFMG1987-04-01
3323371875185864K861092MODEL SP1465 CARDIAC OUTPUT COMPUTERDXG1986-08-18
3323371463919762K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORDRS1986-02-26
3323371161640314K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
3323371157373759K850460VIGGO SECALON T CATHETERFOZ1985-04-11
3323371088156237K843969MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCERDXO1985-01-23
3323371263479928K830523CATHETER CONNECTION W/INTEGRAL INJECTATEDQO1983-03-16
3323371853799956K823296PC-205 TENCKHOFF CATHETER ROD OBTURATORFKX1983-01-26
3323371851314269K821450PRESSURE TUBING-ADULT & PEDIATRICDRS1982-05-25
3323371203800903K811538MODELS TA 1017 & 1017T GRITIFLO DISPOSDRS1981-06-12
3323371297801761K801113DILATOR, VESSEL, FOR PERC. CATHETER.DRE1980-07-28
3323371346313540K791844CRITIFLO & CRITIFLO DOMEKRA1979-10-02
3323371684585127K252892SCOUT MD Surgical Guidance SystemNEU2025-12-19
3323371549754392K252674Solo Pace Fusion System (SOLOFUSE1)DQX2026-01-09
3323371759837564K252527Surfacer Inside-Out Access Catheter SystemQJH2025-09-10
3323371227117137K251802STAR RF Ablation SystemGXI2026-02-13
3323371737355045K251265Resilience Fully Covered Esophageal Stent SystemESW2025-07-23
3323371116469686K250909Prelude Wave Hydrophilic Sheath IntroducerDYB2025-04-25
3323371500456253K250853Merit SyringeFMF2025-11-04
3323371323731005K242873Ventrax™ Delivery SystemDQY2025-01-15
3323371876098045K242229Micro Ace Gold Advanced Micro Access SystemDRE2025-01-15
3323371834052538K241781Solo Pace ControlDTE2025-01-10
3323371227982546K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE2024-04-26
3323371899877323K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH2024-07-24
3323371771016343K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)KRD2024-05-02
3323371304852084K233268Impress Angiographic CatheterDQO2024-05-22
3323371007865637K232609Micro Ace™ Advanced Micro Access SystemDRE2023-09-27
3323371388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
3323371571817268K230636Maestro MicrocatheterKRA2023-03-30
3323371437350721K230418Mighty Wire Guide WireDQX2023-10-28
3323371930057323K223872Low Profile Companion SheathDYB2023-01-19
3323371843515775K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS2023-03-17
3323372048761327K213845HeRO GraftDSY2022-08-15
3323371835782116K213434Elation Pulmonary Balloon Dilation CatheterKTI2022-03-08
3323371109772545K212882SCOUT BX Delivery SystemNEU2022-04-08
3323371641674125K212696Aspira Pleural Drainage SystemDWM2023-03-03
3323371815942949K212675Aspira Peritoneal Drainage SystemPNG2021-12-14
3323371060185167K212199ASAP Aspiration Catheter, ASAPLP Aspiration CatheterQEZ2021-11-03
3323371174118912K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerDYB2022-01-07
3323372045283295K211525SwiftNINJA Steerable MicrocatheterKRA2021-07-16
3323372035533355K211405Prelude Guide SheathDYB2021-10-04
3323371641400896K203724HeRO Graft, HeRO AdapterDSY2021-05-25
3323371729048806K201595Merit Hydrophilic Guide WireDQX2020-10-14
3323372067222822K201166Temno Elite Biopsy SystemKNW2020-08-28
3323371149658667K193571Go2Wire Guide WireDQX2020-04-08
3323372000952041K193507Merit ONE Snare SystemMMX2020-01-17
3323371951561052K193082Fountain ValveTip Infusion CatheterKRA2020-08-07
3323371753322922K193036C2 CryoBalloon EndoGripOCX2019-11-22
3323371293186696K191608Impress Angiographic CatheterDQO2019-07-16
3323372019387955K191596Arcadia Balloon CatheterHRX2019-10-09
3323371915083061K190175S-MAK XLDRE2019-04-10
3323371588854537K182944Dr. Amplatz Micro PlugKRD2019-04-17
3323371238575322K182279Merit SyringeFMF2018-11-06
3323371071255089K182216Merit SyringeFMF2018-11-06
3323371999588746K181669ConvertX Biliary Stent SystemFGE2019-03-14
3323371282987888K181200AEROmini Tracheobronchial Stent SystemJCT2018-09-21
3323371057030621K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU2018-08-02
3323371012652458K180723PreludeSYNC DISTAL Radial Compression SystemDXC2018-04-17
3323371046757651K180450Corvocet Biopsy SystemKNW2018-03-12
3323371343519939K173750Prelude IDeal Hydrophilic Sheath IntroducerDYB2018-02-15
3323371730780946K173601Merit SyringeFMF2018-01-31
3323371358717141K173548Merit Pursue MicrocatheterDQY2018-03-30
3323371198224465K172637HeRO GraftDSY2017-11-30
3323371379478253K172372QuadraSphere MicrospheresKRD2017-09-06
3323371824741574K172117Prelude Pursuit Splittable Sheath IntroducerDYB2017-09-11
3323371277128208K172081Maestro MicrocatheterKRA2017-08-04
3323371877293097K170933Merit Hydrophilic Guide WireDQX2017-06-22
3323371887409229K170700Inqwire Diagnostic Guide WireDQX2017-04-06
3323371482185045K170668HeartSpan Steerable Sheath IntroducerDYB2017-04-05
3323371094850246K170532True Form Reshapable Guide WireDQX2017-07-21
3323372072895685K163597VacLok AT Vacuum SyringePUR2017-07-27
3323371381905025K163575Inqwire Diagnostic Guide WireDQX2017-03-03
3323371639290438K163084Merit Coronary Control SyringeDXT2017-06-15
3323371894386063K162988PreludeSYNC Radial Compression DeviceDXC2017-01-25
3323371868019912K162777Squirt Fluid Delivery SystemQEY2016-10-31
3323371343217284K161921SwiftNINJA MicrocatheterKRA2016-11-04
3323371086042338K161392Elation Pulmonary Balloon DilationKTI2016-09-01
3323371328074689K161277ConvertX Nephroureteral Stent SystemFAD2016-11-22
3323371876718580K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeDXT2016-07-29
3323371765702182K153502ClariVein ICKRA2016-01-06
3323371815269655K153337Corvocet Biopsy SystemKNW2016-03-25
3323371529956482K152783Merit 20 mL SyringeFMF2015-12-07
3323371905038004K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerDYB2015-10-30
3323371060103238K152310HeartLight Deflectable SheathDRA2016-02-24
3323371108344441K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerDYB2015-08-27
3323371741455141K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMSD2016-04-04
3323371509335028K151925Elation Wireguided Balloon Dilation CatheterFGE2015-11-06
3323371314027738K151497EN Snare Endovascular Snare SystemMMX2015-07-01
3323371814813083K151373Corvocet Coaxial IntroducerFCG2015-08-07
3323371228593879K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlNDN2015-04-09
3323372048618403K150257PreludeEASE Hydrophilic Sheath IntroducerDYB2015-06-19
3323371613884623K150083Sidecar External Working ChannelFED2015-04-14
3323371902301861K143255Prelude SNAP Splittable Sheath IntroducerDYB2015-04-09
3323371789618212K142806DualCapQBP2015-05-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX202026-01-09
DYB202025-04-25
DRE92025-01-15
DQO82024-05-22
KRA82023-03-30
FMF72025-11-04
MSD72016-04-04
FJS72012-05-21
DXT62017-06-15
NDN62015-04-09
DQY52025-01-15
DRS52023-03-17
KNW52020-08-28
NEU42025-12-19
DSY42022-08-15
MMX42020-01-17
JCT42018-09-21
DXC42018-04-17
QEY42016-10-31
ESW32025-07-23
KRD32024-05-02
QEZ32021-11-03
FGE32019-03-14
FCG32015-08-07
QSY32013-07-09
QJH22025-09-10
DWM22023-03-03
KTI22022-03-08
JAQ22010-07-12
FPA22008-12-23
FOZ22004-01-29
GXI12026-02-13
DTE12025-01-10
GEH12024-07-24
ODE12024-04-26
PNG12021-12-14
OCX12019-11-22
HRX12019-10-09
PUR12017-07-27
NOY12017-06-21