Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006950086

FEI Number

3006950086

Entity Name

Merit Medical Nederland BV

City/State/Country

Maastricht Airport Limburg, NL

Establishment Address

Amerikalaan 42, Maastricht Airport Limburg 6199 AE, NL

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

Expiration Date (Year)

2026

510(k) Number

K130259

PMA Number

N/A

All Registered Proprietary Names

Aero DV Tracheobronchial Stent System Ventrax Delivery System Maestro Microcatheter K14 Dialysis Kit Elation Wireguided Balloon ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit Guidewire with Palladium Tip BioSentry Tract Sealant System Preston Transpedicular Introducer Preston Hard Bone Access Needle with Drill Preston Bone Filler HeartSpan Steerable Sheath Introducer ClariVein IC Infusion Catheter Alimaxx E Vessel Dilator InQwire Merit HeRO Graft SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Meritrans Disposable Transducer Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Concierge Guiding Catheter Aspira Peritoneal Drainage System Fountain Catheter/Occluding Guide Wire Fountain 4F Catheter & Occluding GW Spectraject Control Syringe ReSolve Dilators Non-vascular tissue dilators K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Performa Diagnostic Intravascular Catheter Safedraw Blood Sampling System ER2 Saturate Mixing System Micro Plug Set First PICC SL Kit SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System Flex-Neck Extender/Repair Kit PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK K10 Waste Management Kit K10T - Waste Management Kit S-MAK XL Embedding Tool 5.5 F Worley Advanced LVI Lateral Vein Introducer Faller Trocar Osseoflex SB Steerable Balloon (8ga) Hydrophilic Guidewire RadialFlo DriPAD Super Absorbent Pad Flex-Neck Infant Catheter Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) HeRO Graft AEROmini Tracheobronchial Stent System SCOUT Console and Accessory Cart Aero Tracheo Stent and Delivery System Rad Rest Maestro Microcatheter TruCut 18Ga SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces Critikit Plus In-Line Room/ Ice Injectate Siege Vascular Plug Safety Paracentesis Tray (SPPT) Drainage Tubing SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. SCOUT Bx Delivery System PreludeEASE Hydrophilic Sheath Introducer, 7F OuTake Catheter Extractor SureCross Support Catheter DiamondTOUCH Inflation Device and Fluid Dispensing Syringe Prelude Plastic Jacketed Guide Wire Repositional Chest Tube RTT14038MB MiniStop Filter Closed Waste Basin Merit Pursue Microcatheter ExxTended Catheter 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 K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit Exacta Percutaneous Sheath Introducer Merit Triboglide Syringe Osseoflex SB Straight Balloon (8ga) EmboGold Microspheres Merit HeRO Graft ASAP Catheter PinVise Torque Device Wrapsody Cell-Impermeable Endoprosthesis Prelude Sheath Half Size (ACT) Prelude Sheath Introducer ROSE TruCut 14Ga Pressure Infusor Bags (PIB) Prelude SNAP Splittable Sheath Introducer STATSEAL WOUNDSEAL StabiliT Introducer and Delivery Instruments Maxxwire Elation Pulmonary Balloon PreludeSYNC EZ Radial Compression Device HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Micro Ace Advanced Micro Access System Sidecar External Working Channel (FG-1011) ReSolve Biliary Locking Drainage Catheter SwiftNINJA Microcatheter Solo Pace Control ASAP Aspiration Catheter ASAPLP Aspiration Catheter Go2Wire Guide Wire Merit Disposal Depot Fountain ValveTip Infusion Catheter Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing K16 Microcatheter Kit SafT Needle Direct Blood Transfer Dash 9F Hydrophilic Sheath Introducer Aspira Peritoneal Drainage System Merit Drainage Depot SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator HeartLight Deflectable Sheath InQwire Diagnostic (Support) Non-Vascular Guide Wire K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Resilience Fully Covered Esophageal Stent System Pinvise Torque Device SeaDragon Torque Device HeRO Graft Physiological Reusable Pressure Transducer Adjustable Biopsy Port Seal BPS-A Corvocet Coaxial Introducer Merit Convenience Kits Prelude Prestige Splittable Sheath Introducer PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Sterilized Convenience Kits Osseoflex SB Steerable Balloon (10Ga) Insufflation Set EndoMAXX SwiftNINJA Steerable Microcatheter SafeGuard Focus Compression Device SafeGuard Focus Cool Device WOUNDSEAL STATSEAL Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome ProGuide Long Term Hemodialysis Catheter Secalon T Catheter Pericardiocentesis Catheter Kit Corvocet Biopsy System Aspira Peritoneal Drainage System Prelude Wave Hydrophilic Sheath Introducer AEROmini Tracheobronchial Stent System Monarch Syringe Fluid Dispense System Duramax Prelude Short Sheath Introducer Safeguard Pressure Assisted Dressing (24cm) One Snare Endovascular Snare System ONE1501 Worley Impress Angiographic Catheter DuraFlow 2 Hemodialysis Catheter Prelude Sheath Introducer First Midcath SL Kit SAVI Prep Device SAVI Spacer Temno Original Temno ACT Universal Coaxial Needles C2 Cryoballoon Endogrip Stylette (rod obturator) Achieve Pink Achieve VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston Transpedicular Drill Preston Hard Bone Introducer Preston Long Drill Novatome Endomyocardial Biopsy Forceps K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter Merit Syringe EsophyX Z+ Device Flex-Neck Catheter True Form Reshapable Guide Wire Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer Revolution Catheter Securement Dev. Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Impress with Legato Hydrophilic Coating Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Smart Tip Control Syringe MultiPlex II Controller Activation Element, ERx bone cement VacLok AT Syringe Low Profile Companion Sheath Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) 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) Ostial Pro Stent Positioning System Safeguard Radial Compression Device STATSEAL WOUNDSEAL Intellisystem Inflation Device Fluid Dispensing Syringe ReSolve ConvertX Nephroureteral Stent System K13 Label Kit Critiflo Disposable Diaphragm Dome One-Vac Evacuated Drainage Bottle FlowGuard BioFlo Duramax Guidewire Introducer MAP Torque Device & Introducer Aspira Pleural Drainage System Prelude Sheath Introducer Finale Radial Compression System RADstat Radial Artery Compression Device Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe Maestro Microcatheter Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Safety MST Kit ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter Surfacer Inside-Out Access Catheter System TRAM-P TRAM Elation Pulmonary Balloon 4mm SAVI Applicator Kit Corvocet Biopsy System Squirt Fluid Delivery System Miser Contrast Management System Bearing nsPVA Embolization Particles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2009-06-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2009-01-06
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2018-08-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2015-12-16
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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2009-11-09
OMT	Absorbable Lung Biopsy Plug	General, Plastic Surgery	Class 2	878.4755	2023-06-08
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-12-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-04-06
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-01-18
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-06-12
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-17
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
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-11-28
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-12-07
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-05-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-09-19
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2020-09-02
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2006-08-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2006-08-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-12-07
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2007-12-07
DQF	Actuator, Syringe, Injector Type	Cardiovascular	Class 2	870.1670	2017-02-17
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-07-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-04-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-02-17
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2016-08-05
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-12-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-11-04
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-10-28
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2018-08-01
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2019-04-10
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-10-09
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
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	2007-12-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-01-20
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-08-26
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-09-09
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
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2018-09-26
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2021-01-27
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2011-09-15
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-10-24
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-09-05
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-01-19
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2017-02-17
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-05-06
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2023-03-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-17
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-06-23
ODY	Tunneled Catheter Remover	General Hospital	Class 2	880.5970	2009-02-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-04-05
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-12-18
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-15
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2013-12-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-02
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2013-11-11
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2018-08-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-02-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-01-26
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
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2011-05-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2024-12-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-04-02
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2003-12-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-14
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-11
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2016-09-06
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-01-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-02-19
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-10-09
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-09-19
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	2016-11-09
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2026-04-14
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2021-11-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-04-09
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-02-17
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2018-08-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2017-02-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-10
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2018-03-15
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2017-07-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-08-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-06-30
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2017-06-30
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-08
OEX	Cardiovascular Catheter Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2018-08-01
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2025-07-24
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2017-07-27
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
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2017-02-17
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-02-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-08-20
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2015-05-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-04-18
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-11
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-07-27
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-12-21
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2011-09-02
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-07-22
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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-08-05
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2011-05-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2020-11-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-13
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2020-09-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-05
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2014-12-09
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
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-12-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2020-01-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-03-27
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-08-05
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2025-01-22
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2018-08-01
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-06-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-02-10
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Gastroenterology, Urology	Class 2	876.1500	2024-07-31
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
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-10-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-02-17
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-02-14
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-10-21
DRC	Trocar	Cardiovascular	Class 2	870.1390	2007-12-07
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-07
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2016-08-05
PUR	Vacuum Syringe	General Hospital	Class 2	880.5860	2017-07-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-01-23
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-16
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2014-03-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-12-11
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
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2006-08-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-07-12
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2018-08-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-06-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-07-31
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2018-07-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2023-04-04
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-08-21
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2003-06-05
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
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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2003-06-05
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2023-06-14
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
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-03-09
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-28
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2016-11-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-04-12
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

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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

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-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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3009582362	OXFORD PERFORMANCE MATERIALS, INC.	South Windsor, CT, US
3012536737	Merit Medical Canada Ltd.	Markham Ontario, CA
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006950086. Last updated year: 2026. Please use registration number 3006950086 when referencing this establishment in official correspondence.