Merit Medical UK Limited

FDA Device Registration & Listing · Earley Reading, GB · Registration 3015309643

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015309643
FEI Number
3015309643
Entity Name
Merit Medical UK Limited
City/State/Country
Earley Reading, GB
Establishment Address
Unit 27, Suttons Business Park Sutton Park Avenue, Earley Reading RG6 1AW, GB
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Merit Medical Systems, Inc. (Owner Number: 1721504)
Owner / Operator Contact Address
1600 West Merit Parkway, --, South Jordan, UT 84095, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Maestro Microcatheter Osseoflex SB Straight Balloon (10ga) Flex-Neck Extender/Repair Kit Merit Convenience Kits Worley Impress Angiographic Catheter PreludeEASE Hydrophilic Sheath Introducer, 7F Prelude IDeal Hydrophilic Sheath Introducer Prelude Wave Hydrophilic Sheath Introducer ReSolve ConvertX Biliary Stent System Prelude Prestige Splittable Sheath Introducer Temno Elite Biopsy Systems Physiological Reusable Pressure Transducer C2 Cryoballoon Ablation System Aspira Peritoneal Drainage System VACLOK Syringe K02 Syringe Kit (multiple K01) Dash 9F Hydrophilic Sheath Introducer Monarch Syringe Fluid Dispense System Flex-Neck Infant Catheter Merit InQwire® Amplatz Super Stiff Guide Wire basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Merit Administration Set CT Transfer Set DriPAD Super Absorbent Pad Corvocet Biopsy System SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) ShortStop Grandstand Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder BackStop Plus Closed Waste Basin Kensington Guide Wire Bone Biopsy System Madison™ Perforating Bone Biopsy System with Drill Westbrook™ Bone Biopsy System Madison Mini™ Bone Biopsy System Bedford™ Guided Hard Bone Biopsy System Huntington Guided, Perforating Bone Biospy System with Drill Tubing, Fluid Delivery InQwire Guidewires Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon OuTake Catheter Extractor K13 Label Kit Ventrax Delivery System PinVise Torque Device Elation Wireguided Balloon Pressure Tubing PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Safeguard Pressure Assisted Device (12cm) Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. Adjustable Biopsy Port Seal BPS-A K08 Fluid Management Kit K04 - Tubing Kit Osseoflex CD-H Hydraulic Cement Delivery System ASAP Catheter Micro Plug Set Impress with Legato Hydrophilic Coating One-Vac Evacuated Drainage Bottle SCOUT Bx Delivery System Duramax Performa Diagnostic Intravascular Catheter HeartLight Deflectable Sheath SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System Resilience Fully Covered Esophageal Stent System Hydrophilic Prelude SNAP Splittable Sheath Introducer Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Maestro Microcatheter Aspira Pleural Drainage System Elation Pulmonary Balloon 4mm AEROmini Tracheobronchial Stent System Surfacer Inside-Out Access Catheter System Merit HeRO Graft Fountain 4F Catheter & Occluding GW Temno Original Temno ACT DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter ER2 Saturate Mixing System Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Corvocet Biopsy System Low Profile Companion Sheath SwiftNINJA Steerable Microcatheter K14 Dialysis Kit Critiflo Dome Critiflo Achieve Pink Achieve Wrapsody Cell-Impermeable Endoprosthesis Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Repositional Chest Tube RTT14038MB Safedraw Blood Sampling System Osseoflex SB Straight Balloon (8ga) InQwire PreludeSYNC EZ Radial Compression Device Slip-Not Perchik Button Assembly ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit HeRO Graft Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome ASAP Aspiration Catheter ASAPLP Aspiration Catheter Secalon T Catheter Osseoflex SB Steerable Balloon (10Ga) InQwire Guidewire-Prelude Introducer K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board Merit Triboglide Syringe Quick Silver Corvocet Coaxial Introducer Exacta Percutaneous Sheath Introducer Finale Radial Compression System RADstat Radial Artery Compression Device SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) SAVI Applicator Kit EsophyX Z+ Device SafT Needle Direct Blood Transfer Mighty Wire Prelude Short Sheath Introducer HeRO Graft Aspira Pleural Drainage System Aero Tracheo Stent and Delivery System Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Elation Pulmonary Balloon Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter Concierge Guiding Catheter Fountain Catheter/Occluding Guide Wire RXP (Rapid Exchange Flushing Syringe) Maestro Microcatheter ClariVein IC Infusion Catheter ReSolve Biliary Locking Drainage Catheter Fountain ValveTip Infusion Catheter Careflow Central Venous Catheter Stylette (rod obturator) PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK TRAM-P TRAM Cuff Implantor Sterilized Convenience Kits K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) Impress and Impress Legato Hydrophilic Angiographic Catheter Prelude Sheath Introducer Roadster Guide Sheath EvenMore Chronic Hemodialysis Catheter Aero DV Tracheobronchial Stent System ReSolve ConvertX Nephroureteral Stent System K12 Procedure Kit K19 Combination Packs K05 Inflation Kit K23C Vein Accessory Kit K22C Vein Tray K12T - Procedure Kit K05T - Inflation Kit 10Fore Hemostasis Valve Kit K02-00873A, K02-01105A, K02-01481A EmboGold Microspheres Guidewire with Palladium Tip EN Snare Endovascular Snare System ROSE C2 Cryoballoon Endogrip Merit Hydrophilic Guide Wire InQwire Diagnostic (Support) Non-Vascular Guide Wire DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System K16 Microcatheter Kit Solo Pace Control ExxTended Catheter True Form Reshapable Guide Wire Hydrophilic Guidewire Pericardiocentesis Catheter Kit S-MAK XL Safety Paracentesis Tray (SPPT) Drainage Tubing Smart Tip Control Syringe Faller Trocar Surfacer Inside-Out Access Catheter System Alimaxx E InQwire TruCut 14Ga Miser Contrast Management System Osseoflex SB Steerable Balloon (8ga) Safeguard Radial Compression Device Thoracentesis Tray (TAPS) Merit HeRO Graft ProGuide Long Term Hemodialysis Catheter Meritrans Disposable Transducer HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath MultiPlex II Controller Activation Element, ERx bone cement SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Merit 1mL Syringe (COP) Peritoneal Dialysis Catheter Connector Aspira Peritoneal Drainage System Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M) Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411) Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211) BioFlo Duramax Critiflo Disposable Diaphragm Dome STATSEAL WOUNDSEAL Safeguard Pressure Assisted Dressing (24cm) WOUNDSEAL STATSEAL STATSEAL WOUNDSEAL Aspira Peritoneal Drainage System Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit Universal Coaxial Needles DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Guidewire Introducer MAP Torque Device & Introducer Merit Safety Needle AEROmini Tracheobronchial Stent System Impress UAC Catheter Novatome Endomyocardial Biopsy Forceps Critikit Plus In-Line Room/ Ice Injectate StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT MX Fracture Kits StabiliT VP Vertebrosplasty Kit StabiliT VP Fracture Kits StabiliT MX Fracture Kits with PowerCURVE StabiliT Bone Cement and Saturate Mixing System Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-03-31
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2023-03-31
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-05-18
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-06-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-02-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-09-12
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2020-12-08
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2017-02-17
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2026-05-08
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2020-09-02
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-01-10
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2007-12-07
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2007-12-07
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-04-07
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2017-07-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-07
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2015-08-26
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-03-28
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2018-11-28
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-05-25
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2001-07-14
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2017-02-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-16
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2015-05-01
ODY Tunneled Catheter Remover General Hospital Class 2 880.5970 2009-02-20
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2018-08-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-02-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-12-16
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2017-02-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2018-04-18
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2016-03-30
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2012-04-12
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2012-04-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-21
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-02-14
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2018-07-17
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2017-07-27
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2011-05-26
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2018-07-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2020-12-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-10-21
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2021-06-23
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2022-08-25
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-06-30
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2017-06-30
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2024-11-04
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2025-07-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-11-02
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2003-12-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-10-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2009-01-06
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2023-04-04
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2022-03-09
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-12-09
QJH Reverse Central Venous Recanalization System Cardiovascular Class 2 870.1342 2023-06-14
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2021-06-02
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2021-06-02
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2021-06-02
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2007-12-07
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-03-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-02-17
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2016-04-18
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-08-05
DRC Trocar Cardiovascular Class 2 870.1390 2007-12-07
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-01-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-07-22
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2018-08-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-02-17
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-15
PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown Class 3 N/A 2024-12-20
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-17
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2017-11-15
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2017-02-17
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-17
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2017-01-25
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-06-27
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2026-04-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-04-16
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2022-08-15
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2022-08-15
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2022-08-15
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-08-05
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2021-11-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-02-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
LOD Bone Cement Orthopedic Class 2 888.3027 2017-07-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
OEX Cardiovascular Catheter Sheath Introducer Kit Cardiovascular Class 2 870.1340 2018-08-01
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2013-10-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-07
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2010-12-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2015-08-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-02-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-09-19
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2003-06-05
FQM Bandage, Elastic General Hospital Class 1 880.5075 2020-09-09
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2018-11-28
ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Gastroenterology, Urology Class 2 876.1500 2024-07-31
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2017-02-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-11-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-12-11
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2016-02-09
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2016-02-09
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2016-02-09
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2023-10-18
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2011-09-15
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-02-07
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2016-09-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-06-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-09-19
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2006-08-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2006-08-11
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2003-12-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-09-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-01-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-12-02
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-08-07
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-02-17
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2012-12-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-10-28
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2011-10-21
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2011-10-21
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2012-12-21
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2008-04-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-04-12
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-08-16
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2013-08-21
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2021-10-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2021-10-26
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2009-06-10
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-07-12
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2018-08-01
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-01-26
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2009-11-09
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2015-07-03
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2017-02-17
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2026-05-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-06-27
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-03-08
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2016-08-09
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2016-08-09
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2007-12-07
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2018-08-01
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2026-04-14
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-17
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2020-11-20
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2019-04-10
PYC Paracentesis Tray General, Plastic Surgery Class 1 878.4200 2023-03-10
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2007-12-07
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
QJH Reverse Central Venous Recanalization System Cardiovascular Class 2 870.1342 2025-12-19
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2009-06-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-16
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-04-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-04-12
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2014-11-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2023-05-19
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2017-12-05
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2017-12-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2017-12-05
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2011-05-17
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-02-19
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-08-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-22
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2012-12-21
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2018-03-15
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2014-03-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2017-02-17
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2020-09-02
HXG Tamp Orthopedic Class 1 888.4540 2019-11-05
HRX Arthroscope Orthopedic Class 2 888.1100 2019-11-05
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-11-05
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2018-03-27
QBP Cap, Device Disinfectant General Hospital Class 2 880.5440 2017-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-19
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2018-09-26
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2019-08-08
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2025-01-22
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2017-02-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

John Knorpp Business: MERIT MEDICAL SYSTEMS, INC. Email: jknorpp@merit.com Phone: (801) 2084389

Related Public Records

Same Entity

Merit Medical Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US
3012276280 KA Medical Arden Hills, MN, US
2032338 Merit Medical Systems, Inc. ALISO VIEJO, CA, US
1125782 MERIT MEDICAL SYSTEMS, INC Chester, VA, US
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2017 Merit Medical Systems, Inc. 2
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0008-2008 Lemaitre Vascular, Inc. 2
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05 Medrad Inc 2
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Similar Registrations

Registration Number Establishment Name Location
3038791046 LIQUET MEDICAL INC. Glen Allen, VA, US
3013134719 HEXACATH Rueil Malmaison Ile-de-France, FR
3026567963 ENDOVASCULAR ENGINEERING, INC. Menlo Park, CA, US
3021067373 VVT MED Ltd Kfar Saba Central, IL
3019525998 VASCUPATENT MEDICAL (SHENZHEN) CO., LTD Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015309643. Last updated year: 2026. Please use registration number 3015309643 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.