Data / Medical devices / Netherlands / Merit Medical Nederland BV

Merit Medical Nederland BV: FDA-registered device maker in Maastricht Airport Limburg, Netherlands, 194 510(k) clearances and 1 PMA approval

Name: Merit Medical Nederland BV FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Merit Medical Nederland BV is registered with the FDA (registration 3006950086) in Maastricht Airport Limburg, Netherlands. It lists 129 device types. The FDA files 194 510(k) clearances and 1 PMA approval under its listings, the newest dated February 13, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006950086
Address: Amerikalaan 42, Maastricht Airport Limburg, Netherlands, 6199 AE
Owner or operator: Merit Medical Systems, Inc. (1721504)
Roles: Exporter to the US
First device listed: July 14, 1992
Registered through: 2027
Brand names listed: 1 mL syringe(Polypropylene), 10Fore Hemostasis Valve, 10Fore Hemostasis Valve Kit, 5.5 F Worley Advanced LVI Lateral Vein Introducer, AEROmini Tracheobronchial Stent System, ARC Catheter, ASAP Aspiration Catheter, ASAP Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Absorbable Lung Biopsy Plug	OMT	2	Exporter to the US	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Exporter to the US	accessdata.fda.gov
Actuator, Syringe, Injector Type	DQF	2	Exporter to the US	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Exporter to the US	accessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine Fibroids	NAJ	2	Exporter to the US	accessdata.fda.gov
Angiography/Angioplasty Kit	OEQ	2	Exporter to the US	accessdata.fda.gov
Apparatus, Suction, Patient Care	DWM	2	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Aspiration Thrombectomy Catheter	QEZ	2	Exporter to the US	accessdata.fda.gov
Bag, Bile Collecting	EXF	2	Exporter to the US	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US	accessdata.fda.gov
Biopsy Needle	FCG	2	Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US	accessdata.fda.gov
Blade, Scalpel	GES	1	Exporter to the US	accessdata.fda.gov
Bone Cement	LOD	2	Exporter to the US	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Exporter to the US	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Exporter to the US	accessdata.fda.gov
Cap, Device Disinfectant	QBP	2	Exporter to the US	accessdata.fda.gov
Cardiovascular Catheter Sheath Introducer Kit	OEX	2	Exporter to the US	accessdata.fda.gov
Cardiovascular Procedure Kit	OEZ	2	Exporter to the US	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Exporter to the US	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Exporter to the US	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Exporter to the US	accessdata.fda.gov
Catheter, Embolectomy	DXE	2	Exporter to the US	accessdata.fda.gov
Catheter, Hemodialysis, Implanted	MSD	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Exporter to the US	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Exporter to the US	accessdata.fda.gov
Catheter, Peritoneal Dialysis, Single Use	FKO	2	Exporter to the US	accessdata.fda.gov
Catheter, Peritoneal, Long-Term Indwelling	FJS	2	Exporter to the US	accessdata.fda.gov
Catheter, Steerable	DRA	2	Exporter to the US	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Exporter to the US	accessdata.fda.gov
Clamp, Vascular	DXC	2	Exporter to the US	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Exporter to the US	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Exporter to the US	accessdata.fda.gov
Device, Biopsy, Endomyocardial	DWZ	2	Exporter to the US	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Exporter to the US	accessdata.fda.gov
Device, Measuring, For Panendoscope	FDY	1	Exporter to the US	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Exporter to the US	accessdata.fda.gov
Device, Percutaneous Retrieval	MMX	2	Exporter to the US	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Exporter to the US	accessdata.fda.gov
Dialysis Administration Kit	PEV	2	Exporter to the US	accessdata.fda.gov
Dilator, Catheter	GCC	1	Exporter to the US	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Exporter to the US	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Exporter to the US	accessdata.fda.gov
Dispenser, Cement	KIH	1	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Endoscope Introducer Kit	NWU	2	Exporter to the US	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Exporter to the US	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Exporter to the US	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Exporter to the US	accessdata.fda.gov
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	ODE	2	Exporter to the US	accessdata.fda.gov
Fluid Drainage Tray	PXU	1	Exporter to the US	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Exporter to the US	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Exporter to the US	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Exporter to the US	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Exporter to the US	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Exporter to the US	accessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)	OAR	1	Exporter to the US	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Exporter to the US	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Exporter to the US	accessdata.fda.gov
Intravenous Extension Tubing Set	OJA	2	Exporter to the US	accessdata.fda.gov
Introducer, Catheter	DYB	2	Exporter to the US	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Exporter to the US	accessdata.fda.gov
Label Or Tag, Sterile	LYV	1	Exporter to the US	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Exporter to the US	accessdata.fda.gov
Mechanical Thrombolysis Catheter	QEY	2	Exporter to the US	accessdata.fda.gov
Minor Surgical Procedures Tray	PYB	1	Exporter to the US	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Needle, Biopsy, Cardiovascular	DWO	1	Exporter to the US	accessdata.fda.gov
Needle, Catheter	GCB	1	Exporter to the US	accessdata.fda.gov
Non-Bronchoscopic Bronchoalveolar Lavage Catheter	OYI	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Paracentesis Tray	PYC	1	Exporter to the US	accessdata.fda.gov
Peripheral Catheter Insertion Kit	OWL	2	Exporter to the US	accessdata.fda.gov
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	PNG	2	Exporter to the US	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Exporter to the US	accessdata.fda.gov
Probe, Thermodilution	KRB	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Tracheal, Expandable	JCT	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	DSY	2	Exporter to the US	accessdata.fda.gov
Pulse-Generator, Pacemaker, External	DTE	2	Exporter to the US	accessdata.fda.gov
Retention Device, Suture	KGS	1	Exporter to the US	accessdata.fda.gov
Reverse Central Venous Recanalization System	QJH	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Single Use Instrument Tray	OJV	1	Exporter to the US	accessdata.fda.gov
Stent, Ureteral	FAD	2	Exporter to the US	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Exporter to the US	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Exporter to the US	accessdata.fda.gov
Stylet, Catheter	DRB	2	Exporter to the US	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Exporter to the US	accessdata.fda.gov
Support, Patient Position	CCX	1	Exporter to the US	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Exporter to the US	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, Applicator, Radionuclide, Remote-Controlled	JAQ	2	Exporter to the US	accessdata.fda.gov
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	PFV	3	Exporter to the US	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
System, Peritoneal, Automatic Delivery	FKX	2	Exporter to the US	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Exporter to the US	accessdata.fda.gov
Tamp	HXG	1	Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US	accessdata.fda.gov
Thoracentesis Tray	PXI	2	Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Exporter to the US	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Exporter to the US	accessdata.fda.gov
Trocar	DRC	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	2	Exporter to the US	accessdata.fda.gov
Tunneled Catheter Remover	ODY	2	Exporter to the US	accessdata.fda.gov
Unit, Cryosurgical, Accessories	GEH	2	Exporter to the US	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Exporter to the US	accessdata.fda.gov
Unit, Filter, Membrane	JRL	1	Exporter to the US	accessdata.fda.gov
Universal Drainage Tray	PPD	2	Exporter to the US	accessdata.fda.gov
Vacuum Syringe	PUR	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 194.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 13, 2026	K251802	STAR RF Ablation System	GXI	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 9, 2026	K252674	Solo Pace Fusion System (SOLOFUSE1)	DQX	Substantially Equivalent	Solo Pace, Inc.	accessdata.fda.gov
December 19, 2025	K252892	SCOUT MD Surgical Guidance System	NEU	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 4, 2025	K250853	Merit Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 10, 2025	K252527	Surfacer Inside-Out Access Catheter System	QJH	Unknown	Merit Medical System, Inc.	accessdata.fda.gov
July 23, 2025	K251265	Resilience Fully Covered Esophageal Stent System	ESW	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 25, 2025	K250909	Prelude Wave Hydrophilic Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 15, 2025	K242873	Ventrax Delivery System	DQY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 15, 2025	K242229	Micro Ace Gold Advanced Micro Access System	DRE	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 10, 2025	K241781	Solo Pace Control	DTE	Substantially Equivalent	Solo Pace, Inc.	accessdata.fda.gov
July 24, 2024	K240457	C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)	GEH	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
May 22, 2024	K233268	Impress Angiographic Catheter	DQO	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
May 2, 2024	K240261	Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)	KRD	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 26, 2024	K240879	EsophyX Z+ Device with SerosaFuse Fasteners and Accessories	ODE	Substantially Equivalent	Endogastric Solutions, Inc.	accessdata.fda.gov
February 12, 2024	K231468	SCOUT MD Surgical Guidance System	NEU	Substantially Equivalent	Merit Medical System, Inc.	accessdata.fda.gov
October 28, 2023	K230418	Mighty Wire Guide Wire	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 27, 2023	K232609	Micro Ace Advanced Micro Access System	DRE	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
March 30, 2023	K230636	Maestro Microcatheter	KRA	Substantially Equivalent	Merit Medical System, Inc.	accessdata.fda.gov
March 3, 2023	K212696	Aspira Pleural Drainage System	DWM	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 19, 2023	K223872	Low Profile Companion Sheath	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 15, 2022	K213845	HeRO Graft	DSY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 8, 2022	K212882	SCOUT BX Delivery System	NEU	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
March 8, 2022	K213434	Elation Pulmonary Balloon Dilation Catheter	KTI	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 7, 2022	K212152	Prelude IDeal 9F Hydrophilic Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems	accessdata.fda.gov
December 14, 2021	K212675	Aspira Peritoneal Drainage System	PNG	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
November 3, 2021	K212199	ASAP Aspiration Catheter, ASAPLP Aspiration Catheter	QEZ	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 4, 2021	K211405	Prelude Guide Sheath	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 16, 2021	K211525	SwiftNINJA Steerable Microcatheter	KRA	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
May 25, 2021	K203724	HeRO Graft, HeRO Adapter	DSY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 14, 2020	K201595	Merit Hydrophilic Guide Wire	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 28, 2020	K201166	Temno Elite Biopsy System	KNW	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 7, 2020	K193082	Fountain ValveTip Infusion Catheter	KRA	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 8, 2020	K193571	Go2Wire Guide Wire	DQX	Substantially Equivalent	Merit Medical System, Inc.	accessdata.fda.gov
February 10, 2020	DEN190038	Surfacer Inside-Out Access Catheter System	QJH	Unknown	Bluegrass Vascular Technologies, Inc.	accessdata.fda.gov
January 17, 2020	K193507	Merit ONE Snare System	MMX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 22, 2019	K193036	C2 CryoBalloon EndoGrip	OCX	Substantially Equivalent	Pentax Medical, A Division of Pentax of America, Inc.	accessdata.fda.gov
October 9, 2019	K191596	Arcadia Balloon Catheter	HRX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 6, 2019	K183120	EmboCube Embolization Gelatin	KRD	Substantially Equivalent	Biosphere Medical, S.A.	accessdata.fda.gov
July 16, 2019	K191608	Impress Angiographic Catheter	DQO	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 17, 2019	K182944	Dr. Amplatz Micro Plug	KRD	Substantially Equivalent	Ka Medical, LLC	accessdata.fda.gov
April 10, 2019	K190175	S-MAK XL	DRE	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
March 14, 2019	K181669	ConvertX Biliary Stent System	FGE	Substantially Equivalent	Brightwater Medical	accessdata.fda.gov
November 6, 2018	K182279	Merit Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 6, 2018	K182216	Merit Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 21, 2018	K181200	AEROmini Tracheobronchial Stent System	JCT	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 2, 2018	K181007	Cianna Medical SAVI Scout Reflector and SAVI Scout System	NEU	Substantially Equivalent	Cianna Medical, Inc.	accessdata.fda.gov
April 17, 2018	K180723	PreludeSYNC DISTAL Radial Compression System	DXC	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
March 30, 2018	K173548	Merit Pursue Microcatheter	DQY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
March 12, 2018	K180450	Corvocet Biopsy System	KNW	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
February 15, 2018	K173750	Prelude IDeal Hydrophilic Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 31, 2018	K173601	Merit Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 30, 2017	K172637	HeRO Graft	DSY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 18, 2017	K170298	Liberator Beacon Tip Locking Stylet	DRB	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
September 11, 2017	K172117	Prelude Pursuit Splittable Sheath Introducer	DYB	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
August 4, 2017	K172081	Maestro Microcatheter	KRA	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 27, 2017	K163597	VacLok AT Vacuum Syringe	PUR	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 21, 2017	K170532	True Form Reshapable Guide Wire	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 11, 2017	K163353	Needle's Eye Snare Retrieval Set - 54cm	DXE	Substantially Equivalent	Cook Incorporated	accessdata.fda.gov
June 22, 2017	K170933	Merit Hydrophilic Guide Wire	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
June 15, 2017	K163084	Merit Coronary Control Syringe	DXT	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
April 5, 2017	K170668	HeartSpan Steerable Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
January 25, 2017	K162988	PreludeSYNC Radial Compression Device	DXC	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 22, 2016	K161277	ConvertX Nephroureteral Stent System	FAD	Substantially Equivalent	Brightwater Medical	accessdata.fda.gov
November 4, 2016	K161921	SwiftNINJA Microcatheter	KRA	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 31, 2016	K162777	Squirt Fluid Delivery System	QEY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 1, 2016	K161392	Elation Pulmonary Balloon Dilation	KTI	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 29, 2016	K160107	DiamondTOUCH Inflation Device and Fluid Dispensing Syringe	DXT	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
April 4, 2016	K151967	Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter	MSD	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
March 25, 2016	K153337	Corvocet Biopsy System	KNW	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
February 24, 2016	K152310	HeartLight Deflectable Sheath	DRA	Substantially Equivalent	Cardiofocus, Inc.	accessdata.fda.gov
January 6, 2016	K153502	ClariVein IC	KRA	Substantially Equivalent	Vascular Insights, LLC	accessdata.fda.gov
December 7, 2015	K152783	Merit 20 mL Syringe	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 6, 2015	K151925	Elation Wireguided Balloon Dilation Catheter	FGE	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 30, 2015	K152381	Prelude SNAP Splittable Hydrophilic Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 27, 2015	K152116	5.5 F Worley Advanced LVI Lateral Vein Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 7, 2015	K151373	Corvocet Coaxial Introducer	FCG	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 1, 2015	K151497	EN Snare Endovascular Snare System	MMX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
June 19, 2015	K150257	PreludeEASE Hydrophilic Sheath Introducer	DYB	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
May 22, 2015	K142806	DualCap	QBP	Substantially Equivalent	Catheter Connections, Inc.	accessdata.fda.gov
April 14, 2015	K150083	Sidecar External Working Channel	FED	Substantially Equivalent	C2 Therapeutics	accessdata.fda.gov
April 9, 2015	K143255	Prelude SNAP Splittable Sheath Introducer	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
December 17, 2014	K142051	PRELUDE PLASTIC JACKETED GUIDE WIRE	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
December 10, 2014	K141054	DISTAL ACCESS TORQUE DEVICE	DQX	Substantially Equivalent	Distal Access, LLC	accessdata.fda.gov
November 26, 2014	K141408	RESOLVE BILIARY LOCKING DRAINAGE CATHETER	FGE	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 25, 2014	K140382	AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY	JCT	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 13, 2014	K142265	ONE Snare Endovascular Microsnare System	MMX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
October 16, 2014	K140543	PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 12, 2014	K140608	MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 5, 2014	K141552	ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS	KNW	Substantially Equivalent	Care Fusion	accessdata.fda.gov
August 21, 2014	K141930	OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML	NDN	Substantially Equivalent	Osseon, LLC	accessdata.fda.gov
July 9, 2014	K140513	MERIT SAFETY INTRODUCER NEEDLE	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
June 19, 2014	K140937	OSSEOFLEX SB	NDN	Substantially Equivalent	Osseon, LLC	accessdata.fda.gov
June 18, 2014	K141363	CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER	MSD	Unknown	Merit Medical Systems, Inc.	accessdata.fda.gov
February 14, 2014	K131260	NMI DIALYSIS CATHETER	MSD	Unknown	Navilyst Medical, Inc.	accessdata.fda.gov
February 12, 2014	K132720	HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
December 12, 2013	K133230	INQWIRE DIAGNOSTIC GUIDE WIRE	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
November 7, 2013	K132155	Merit ASAPLP Aspiration Catheter	QEZ	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
September 17, 2013	K132164	HEARTSPAN STEERABLE INTRODUCER KIT	DYB	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
August 29, 2013	K132409	CONCIERGE GUIDING CATHETER	DQY	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov
July 9, 2013	K130324	STATSEAL DISC	QSY	Substantially Equivalent	Biolife, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 19, 2024	P240023	WRAPSODY® Cell-Impermeable Endoprosthesis	PFV	4	June 11, 2026	accessdata.fda.gov

Compare with other makers

Updated June 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.