Merit Medical Asia Company Limited

FDA Device Registration & Listing · Tsim Sha Tsui, HK · Registration 3015225571

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
3015225571
FEI Number
3015225571
Entity Name
Merit Medical Asia Company Limited
City/State/Country
Tsim Sha Tsui, HK
Establishment Address
Rm 614 6/F Tsim Sha Tsui Center, 66 Mody Road, Tsim Sha Tsui 0000, HK
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
K182279
PMA Number
N/A

All Registered Proprietary Names

Flex-Neck Catheter Sterilized Convenience Kits Safety Paracentesis Tray (SPPT) Drainage Tubing Performa Diagnostic Intravascular Catheter OneSnare Endovascular Snare System Hydrophilic Guidewire Merit Administration Set CT Transfer Set K10 Waste Management Kit K10T - Waste Management Kit OuTake Catheter Extractor K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit InQwire Diagnostic (Support) Non-Vascular Guide Wire Guidewire with Palladium Tip Merit Safety Needle ReSolve ConvertX Nephroureteral Stent System CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter MiniStop Filter Closed Waste Basin Aerosizer BioSentry Tract Sealant System Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Finale Radial Compression System RADstat Radial Artery Compression Device Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) WOUNDSEAL STATSEAL Elation Pulmonary Balloon 4mm Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System Merit Disposal Depot C2 Cryoballoon Endogrip C2 Cryoballoon Ablation System Corvocet Biopsy System SAVI Applicator Kit ReSolve Dilators Non-vascular tissue dilators Prelude Sheath Introducer Impress and Impress Legato Hydrophilic Angiographic Catheter Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Safeguard Pressure Assisted Dressing (24cm) Cuff Implantor Corvocet Biopsy System Merit 1mL Syringe (COP) Thoracentesis Tray (TAPS) Aero Tracheo Stent and Delivery System Prelude Sheath Half Size (ACT) Prelude Sheath Introducer SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Prelude IDeal Hydrophilic Sheath Introducer Flex-Neck Extender/Repair Kit EsophyX Z+ Device Rad Rest Alimaxx E Maestro Microcatheter Smart Tip Control Syringe Osseoflex SB Straight Balloon (10ga) VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill Fountain Catheter/Occluding Guide Wire K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) Go2Wire Guide Wire Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System Rotating Adaptor Stopcock One Port Manifold Hemostasis Valve Adapter SafeSheath Sealing Adapter Merit Manifold DoublePlay Hemostasis Valve MYSHELL Hemostatic Valve FLO30 Honor hemostasis valve Passage Hemostasis Valve FLO40XR Merit Marquis Flow Switch Merit Marquis Stopcock Prelude Choice Hemostasis Valve Adapter PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing Access-9 H20 Torque Device AccessPLUS MBA Check Valve NeoVasc FLO50 10Fore Hemostasis Valve SCOUT Bx Delivery System TruCut 18Ga Prelude SNAP Splittable Sheath Introducer AEROmini Tracheobronchial Stent System ClariVein IC Infusion Catheter Insufflation Set Merit Pursue Microcatheter Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit Osseoflex CD-H Hydraulic Cement Delivery System Merit Drainage Depot DuraFlow 2 Hemodialysis Catheter Safeguard Radial Compression Device ER2 Saturate Mixing System Adjustable Biopsy Port Seal BPS-A EvenMore Chronic Hemodialysis Catheter Brochoalveloar Lavage (BAL) Custom Convenience Kit ASAP Catheter Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Meritrans Disposable Transducer Embedding Tool ARC Catheter SwiftNINJA Microcatheter InQwire Guidewire-Prelude Introducer Prelude Wave Hydrophilic Sheath Introducer Vessel Dilator RXP (Rapid Exchange Flushing Syringe) 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 Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Hydrophilic Prelude SNAP Splittable Sheath Introducer Prelude Short Sheath Introducer Low Profile Companion Sheath Roadster Guide Sheath Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler Safeguard Pressure Assisted Device (12cm) Guidewire Introducer MAP Torque Device & Introducer 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) Siege Vascular Plug EN Snare Endovascular Snare System Temno Original Temno ACT PinVise Torque Device SAVI Prep Device SAVI Spacer Achieve Pink Achieve SPINR High-Performance Guidewire Catheter ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter K16 Microcatheter Kit DriPAD Super Absorbent Pad SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. Temno Elite Biopsy Systems K08 Fluid Management Kit K04 - Tubing Kit Concierge Guiding Catheter Acutiy Universal Cutter Fountain 4F Catheter & Occluding GW Duramax Universal Coaxial Needles EndoMAXX SCOUT Console and Accessory Cart Elation Wireguided Balloon Osseoflex SB Steerable Balloon (8ga) TruCut 14Ga Solo Pace Fusion System (SOLOFUSE1) One-Vac Evacuated Drainage Bottle Stylette (rod obturator) PreludeEASE Hydrophilic Sheath Introducer, 7F Elation Pulmonary Balloon Maestro Microcatheter Merit InQwire® Amplatz Super Stiff Guide Wire Fountain ValveTip Infusion Catheter Impress with Legato Hydrophilic Coating Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer ReSolve Biliary Locking Drainage Catheter 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 Intellisystem Inflation Device Fluid Dispensing Syringe Surfacer Inside-Out Access Catheter System STATSEAL WOUNDSEAL True Form Reshapable Guide Wire PAL (Pen and Labels) Family Aspira Pleural Drainage System TRAM-P TRAM H20 Guidewire Impress UAC Catheter SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces PreludeSYNC EZ Radial Compression Device HeartSpan Steerable Sheath Introducer ASAPLP Embolectomy Catheter Surfacer Inside-Out Access Catheter System Merit HeRO Graft Merit Hydrophilic Guide Wire SafeGuard Focus Compression Device SafeGuard Focus Cool Device STATSEAL WOUNDSEAL X-Change Cement Dispensing Syringe Hydraulic Assembly Osseon Bone Filler Device (BFD) StabiliT Cement Delivery Syringe Hydraulic-Master Syringe Assembly Purge Assist Master Syringe Assembly DiamondTOUCH Syringe Flex-Neck Infant Catheter K14 Dialysis Kit Novatome Endomyocardial Biopsy Forceps Sidecar External Working Channel (FG-1011) SureCross Support Catheter Merit Convenience Kits Aspira Peritoneal Drainage System Slip-Not Perchik Button Assembly Peritoneal Dialysis Catheter Connector Dash 9F Hydrophilic Sheath Introducer Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon ReSolve ConvertX Biliary Stent System Worley Impress Angiographic Catheter Mighty Wire Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Futura Safety Scalpel Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe Micro Plug Set Pressure Infusor Bags (PIB) ASAP Aspiration Catheter ASAPLP Aspiration Catheter InQwire Micro Ace Advanced Micro Access System Pericardiocentesis Catheter Kit MultiPlex II Controller Activation Element, ERx bone cement SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Ostial Pro Stent Positioning System Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Miser Contrast Management 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 Aspira Pleural Drainage System Corvocet Coaxial Introducer SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Pinvise Torque Device SeaDragon Torque Device 5.5 F Worley Advanced LVI Lateral Vein Introducer Temno Evolution Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Micro Ace Gold Advanced Micro Access System Squirt Fluid Delivery System HeartLight Deflectable Sheath One Snare Endovascular Snare System ONE1501 Merit Triboglide Syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2008-04-11
PYC Paracentesis Tray General, Plastic Surgery Class 1 878.4200 2023-03-10
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2012-12-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-12-07
PPD Universal Drainage Tray Gastroenterology, Urology Class 2 876.5130 2018-08-01
ODY Tunneled Catheter Remover General Hospital Class 2 880.5970 2009-02-20
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2018-07-19
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2018-08-01
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-03-08
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2009-11-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-11-19
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2019-07-12
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-06-19
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2013-12-06
FDY Device, Measuring, For Panendoscope Gastroenterology, Urology Class 1 876.1500 2009-06-11
OMT Absorbable Lung Biopsy Plug General, Plastic Surgery Class 2 878.4755 2023-06-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-08-05
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2003-06-05
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2022-03-09
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2007-12-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2026-05-08
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2026-05-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-03-28
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2018-11-28
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2014-07-02
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-08-16
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2012-12-21
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-13
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-22
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2023-05-19
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2011-09-15
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
FQM Bandage, Elastic General Hospital Class 1 880.5075 2020-09-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-02-15
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) Gastroenterology, Urology Class 2 876.1500 2024-07-31
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2013-10-24
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2009-06-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2009-01-06
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2007-12-07
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2016-08-05
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2006-08-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2006-08-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-04-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-04-09
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-02-07
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2024-11-04
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-10-14
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2022-08-25
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-04-14
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-12-09
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-01-18
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2012-12-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-04-02
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
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2017-07-27
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2017-07-24
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2013-10-25
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2016-08-05
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-02-14
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
OYI Non-Bronchoscopic Bronchoalveolar Lavage Catheter Anesthesiology Class 1 868.6810 2015-12-09
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2011-05-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-05-25
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2007-12-07
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2016-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-05
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2003-12-18
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2001-07-14
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2013-10-24
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2018-04-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-11-02
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-12-11
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2014-11-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-01-23
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
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-21
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2016-03-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
GBW Catheter, Peritoneal General, Plastic Surgery Class 1 878.4200 2014-03-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2024-05-06
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2015-07-03
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-03-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2018-11-28
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-03-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-01-13
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2003-06-05
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2018-08-01
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2015-08-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-21
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2020-12-08
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2018-07-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-09-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-01-17
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2007-12-07
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2023-06-08
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2018-03-27
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2011-09-02
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2021-01-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-12-16
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-04-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-04-14
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2026-04-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-10-15
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2021-06-23
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2012-12-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-06-23
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2016-09-06
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-04-07
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-08-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-10-21
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2003-12-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-12-02
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2006-08-11
QJH Reverse Central Venous Recanalization System Cardiovascular Class 2 870.1342 2023-06-14
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-24
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2008-10-09
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2023-04-04
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2019-08-08
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2026-01-19
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2017-01-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-04-06
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2013-12-05
QJH Reverse Central Venous Recanalization System Cardiovascular Class 2 870.1342 2025-12-19
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-06-27
MHW Dressing, Compression General Hospital Class 1 880.5075 2020-09-09
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2025-06-02
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2013-11-11
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2012-12-21
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2018-08-01
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2025-01-22
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-05-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-04-05
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-05-18
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2018-03-15
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2013-06-27
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2012-12-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-01-10
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2015-05-01
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-07-12
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-11-20
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-07-27
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 1992-07-14
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2013-06-11
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
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2020-12-14
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2003-12-18
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2021-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-17
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2023-10-09
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2020-11-20
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-08-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-08-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-12-11
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2007-12-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-04-12
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2018-08-01
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2023-10-18
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2015-08-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-01-17
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2017-07-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-10-09
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-03-15
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-17
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-01-22
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2016-11-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-06-30
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2017-06-30
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2020-01-20
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-01-07

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
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

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-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number Establishment Name Location
3015309643 Merit Medical UK Limited Earley Reading, GB
9610849 Covidien TIJUANA, B.C. Mexico, MX
2529647 ACTIVE MEDICAL, INC. HARRISBURG, PA, US
3030574705 MOZARC MEDICAL US LLC Mansfield, MA, US
2011171 Sterigenics US LLC Los Angeles, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015225571. Last updated year: 2026. Please use registration number 3015225571 when referencing this establishment in official correspondence.
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