Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1721504

FEI Number

1721504

Entity Name

MERIT MEDICAL SYSTEMS, INC.

City/State/Country

South Jordan, UT, US

Establishment Address

1600 WEST MERIT PKWY., South Jordan, UT 84095, US

Establishment Type(s)

Manufacture Medical 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

Expiration Date (Year)

2026

510(k) Number

K182279

PMA Number

N/A

All Registered Proprietary Names

Duramax Squirt Fluid Delivery System SPINR High-Performance Guidewire Catheter EndoMAXX 5.5 F Worley Advanced LVI Lateral Vein Introducer Micro Ace Advanced Micro Access System SAVI Prep Device SAVI Spacer VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston Transpedicular Drill Preston Hard Bone Introducer Preston Long Drill SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. MiniStop Filter Closed Waste Basin InQwire Guidewire-Prelude Introducer Merit Disposal Depot ER2 Saturate Mixing System Prelude Plastic Jacketed Guide Wire Pericardiocentesis Catheter Kit Wrapsody Cell-Impermeable Endoprosthesis OneMark Detector Console OneMark DIS Probe 01 OneMark DIS Console & Probe Activities: Manufacturer OneMark Detection Imaging System OneMark Breast Localization Marker Fountain ValveTip Infusion Catheter ReSolve Dilators Non-vascular tissue dilators ARC Catheter Impress and Impress Legato Hydrophilic Angiographic Catheter Resilience Fully Covered Esophageal Stent System CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter ASAP CATHETER Temno Evolution Maestro Microcatheter ASAPLP Embolectomy Catheter Merit InQwire® Amplatz Super Stiff Guide Wire Merit Safety Needle Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter Flex-Neck Infant Catheter Liberator Beacon Tip Locking Stylet Byrd Dilator Sheath Set 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 WOUNDSEAL STATSEAL PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK InQwire Amplatz Super Stiff Guide Wire HeRO Graft Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Rad Rest Safeguard Radial Compression Device Surfacer Inside-Out Access Catheter System Merit HeRO Graft Revolution Catheter Securement Dev. DriPAD Super Absorbent Pad Meritrans Disposable Transducer ExxTended Catheter 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) Osseoflex CD-H Hydraulic Cement Delivery System Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Worley Impress Angiographic Catheter 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 MultiPlex II Controller Activation Element, ERx bone cement Maestro Microcatheter Bearing nsPVA Embolization Particles Maestro Microcatheter Corvocet Coaxial Introducer Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board Prelude Sheath Introducer Insufflation Set K14 Dialysis Kit VacLok AT Syringe Alimaxx E VACLOK Syringe K02 Syringe Kit (multiple K01) K13 Label Kit AEROmini Tracheobronchial Stent System Merit Syringe BioSentry Tract Sealant System SteadySheath & Shortie InQwire PinVise Torque Device STATSEAL WOUNDSEAL SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces SCOUT Console and Accessory Cart Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Aero DV Tracheobronchial Stent System Cool Point Irrigation Pump Evolution RL & Evolution Shortie RL TruCut 14Ga HeRO Graft Quick Silver H20 Guidewire ReSolve ConvertX Biliary Stent System PreludeEASE Hydrophilic Sheath Introducer, 7F SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Elation Pulmonary Balloon Go2Wire Guide Wire C2 Cryoballoon Endogrip Safeguard Pressure Assisted Dressing (24cm) Merit Pursue Microcatheter K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit BioFlo Duramax Cerenovus Aspiration Tubing set Prelude Wave Hydrophilic Sheath Introducer InQwire Super Stiff Guide Wire True Form Reshapable Guide Wire Preston Transpedicular Introducer Preston Hard Bone Access Needle with Drill Preston Bone Filler Aerosizer Temno Elite Biopsy Systems Bearing nsPVA Express Surfacer Inside-Out Access Catheter System C2 Cryoballoon Ablation System Guidewire with Palladium Tip Slip-Not Perchik Button Assembly Peritoneal Dialysis Catheter Connector Adjustable Biopsy Port Seal BPS-A Impress with Legato Hydrophilic Coating SAVI Applicator Kit STATSEAL WOUNDSEAL Low Profile Companion Sheath Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Siege Vascular Plug K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Dash 9F Hydrophilic Sheath Introducer Merit 1mL Syringe (COP) Ventrax Delivery System HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Prelude Prestige Splittable Sheath Introducer ASAP Aspiration Catheter ASAPLP Aspiration Catheter One Snare Endovascular Snare System ONE1501 Impress UAC Catheter InQwire K08 Fluid Management Kit K04 - Tubing Kit Aspira Pleural Drainage System K10 Waste Management Kit K10T - Waste Management Kit basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Corvocet Biopsy System ReSolve Biliary Locking Drainage Catheter Prelude Short Sheath Introducer Micro Ace Gold Advanced Micro Access System Hydrophilic Prelude SNAP Splittable Sheath Introducer Sidecar External Working Channel (FG-1011) Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Prelude SNAP Splittable Sheath Introducer StabiliT Introducer and Delivery Instruments Maxxwire Osseoflex SB Straight Balloon (8ga) Cuff Implantor SafeGuard Focus Compression Device SafeGuard Focus Cool Device Osseoflex SB Steerable Balloon (10Ga) Merit HeRO Graft Monarch Syringe Fluid Dispense System 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 ASAPLP Embolectomy Catheter Corvocet Biopsy System Splashwire Hydrophilic Guide Wire Futura Safety Scalpel FlowGuard Merit Convenience Kits SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System HeartSpan Steerable Introducer Sheath Intellisystem Inflation Device Fluid Dispensing Syringe ASAP Catheter Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System 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 AEROmini Tracheobronchial Stent System Safety Paracentesis Tray (SPPT) Drainage Tubing Smart Tip Control Syringe Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe PreludeSYNC EZ Radial Compression Device ClariVein OC Faller Trocar K16 Microcatheter Kit K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit Surfacer Inside-Out Access Catheter System ProGuide Long Term Hemodialysis Catheter EvenMore Chronic Hemodialysis Catheter ReSolve ConvertX Nephroureteral Stent System Repositional Chest Tube RTT14038MB Osseoflex SB Steerable Balloon (8ga) PAL (Pen and Labels) Family Ostial Pro Stent Positioning System SwiftNINJA Microcatheter Merit Administration Set CT Transfer Set Temno Original Temno ACT DiamondTOUCH Inflation Device and Fluid Dispensing Syringe RXP (Rapid Exchange Flushing Syringe) Performa Diagnostic Intravascular Catheter S-MAK XL EN Snare Endovascular Snare System Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) StayFix Fixation Device Embedding Tool Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) OuTake Catheter Extractor Aero Tracheo Stent and Delivery System Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Concierge Guiding Catheter Pressure Infusor Bags (PIB) Merit Hydrophilic Guide Wire DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Stylette (rod obturator) Roadster Guide Sheath OneSnare Endovascular Snare System Fountain Catheter/Occluding Guide Wire Merit Triboglide Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2016-11-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-01-13
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2011-09-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-10-09
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-10-09
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-08-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2013-12-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2016-08-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-12-18
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2020-11-20
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2024-12-20
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-04-28
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-07
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-07-02
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-08-16
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2025-07-24
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-06-19
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2010-08-11
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
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
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2013-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-11-19
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-04-18
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2026-03-04
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-03-24
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-10-14
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-10-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-03-06
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
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-27
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-10-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2023-06-14
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
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-02-14
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-08-26
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
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2014-03-21
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-07-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-08-01
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2016-08-05
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-09-05
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2013-06-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-06-20
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2009-01-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-08-20
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-10-24
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-08-21
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-12-21
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2018-08-01
PUR	Vacuum Syringe	General Hospital	Class 2	880.5860	2017-07-28
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-06-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-07
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2018-08-01
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2014-12-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-02-10
OMT	Absorbable Lung Biopsy Plug	General, Plastic Surgery	Class 2	878.4755	2023-06-08
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2026-02-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-01-19
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2021-01-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-17
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2009-06-10
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2021-05-12
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-12-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-04-02
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
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2010-12-13
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	2019-07-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-06-23
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-09-09
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2016-09-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-04-09
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-04-12
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-09-19
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-08-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-02-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-07-24
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-12-21
FDY	Device, Measuring, For Panendoscope	Gastroenterology, Urology	Class 1	876.1500	2009-06-11
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-12-08
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2024-02-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-02-06
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2023-06-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-05-08
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2009-11-09
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
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-02-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-10-21
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-01-23
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-12-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-05-06
OEX	Cardiovascular Catheter Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2018-08-01
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
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2003-12-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-02-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-12
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2021-11-09
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2020-01-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-08-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-17
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2018-07-17
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2023-04-04
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2018-08-01
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-07-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-13
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-12-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-12-11
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-01-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-11-02
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-05-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-12-21
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-09-09
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-07-27
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
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
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2021-06-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-10-15
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-02-03
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-06-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-07-31
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2015-05-18
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-11-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2006-08-11
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2011-05-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-12-07
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2007-12-07
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-07-14
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2018-09-26
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
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
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-01-25
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-07-01
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2018-08-01
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2018-08-01
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2025-12-19
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2011-05-17
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-07-12
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2008-10-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-12-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2016-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
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
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-12-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2019-04-10
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2015-07-03
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-09-11
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-07
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2014-11-19
ODY	Tunneled Catheter Remover	General Hospital	Class 2	880.5970	2009-02-20
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2011-09-15
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-09-19
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2003-12-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-06-27
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2017-03-01
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
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
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2012-12-14
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	2020-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31

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
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
3005987240	ALLWIN MEDICAL DEVICES, INC.	ANAHEIM, CA, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
3003915875	MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.	MEXICALI Baja California, MX
3010882065	HEALTH LINE INTERNATIONAL CORPORATION	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1721504. Last updated year: 2026. Please use registration number 1721504 when referencing this establishment in official correspondence.