Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012536737

FEI Number

3012536737

Entity Name

Merit Medical Canada Ltd.

City/State/Country

Markham Ontario, CA

Establishment Address

1 Valleywood Drive, units 4&5, Markham Ontario L3R 5L9, CA

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

K063048

PMA Number

N/A

All Registered Proprietary Names

InQwire Diagnostic (Support) Non-Vascular Guide Wire InQwire Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing Sterilized Convenience Kits Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Aero DV Tracheobronchial Stent System PAL (Pen and Labels) Family HeartSpan Steerable Introducer Sheath Pinvise Torque Device SeaDragon Torque Device Go2Wire Guide Wire Faller Trocar 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 Merit Hydrophilic Guide Wire Novatome Endomyocardial Biopsy Forceps PreludeSYNC EZ Radial Compression Device Ostial Pro Stent Positioning System Exacta Percutaneous Sheath Introducer STATSEAL WOUNDSEAL PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK FlowGuard Merit Triboglide Syringe SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces Surfacer Inside-Out Access Catheter System Elation Wireguided Balloon H20 Guidewire ClariVein IC Infusion Catheter ASAP Catheter Osseoflex SB Straight Balloon (10ga) Alimaxx E Meritrans Disposable Transducer Embedding Tool MultiPlex II Controller Activation Element, ERx bone cement Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Corvocet Coaxial Introducer ARC Catheter Impress UAC Catheter Pericardiocentesis Catheter Kit S-MAK XL ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter Impress with Legato Hydrophilic Coating One Snare Endovascular Snare System ONE1501 WOUNDSEAL STATSEAL Thoracentesis Tray (TAPS) Corvocet Biopsy System Rad Rest Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Preston Transpedicular Introducer Preston Hard Bone Access Needle with Drill Preston Bone Filler Maestro Microcatheter Spectraject Control Syringe Critikit Plus In-Line Room/ Ice Injectate Micro Ace Advanced Micro Access System One-Vac Evacuated Drainage Bottle ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit Finale Radial Compression System RADstat Radial Artery Compression Device HeartLight Deflectable Sheath RXP (Rapid Exchange Flushing Syringe) MiniStop Filter Closed Waste Basin Safeguard Radial Compression Device Solo Pace Fusion System (SOLOFUSE1) K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Fountain ValveTip Infusion Catheter Flex-Neck Extender/Repair Kit ReSolve ConvertX Biliary Stent System SCOUT Bx Delivery System Dash 9F Hydrophilic Sheath Introducer Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Prelude SNAP Splittable Sheath Introducer Temno Elite Biopsy Systems Mighty Wire Aspira Peritoneal Drainage System Micro Plug Set Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Worley Impress Angiographic Catheter Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter BowTie Guide Wire Insertion Device Pressure Infusor Bags (PIB) InQwire True Form Reshapable Guide Wire Intellisystem Inflation Device Fluid Dispensing Syringe Elation Pulmonary Balloon 4mm SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Prelude Prestige Splittable Sheath Introducer SwiftNINJA Steerable Microcatheter Merit 1mL Syringe (COP) Prelude Wave Hydrophilic Sheath Introducer SureCross Support Catheter Corvocet Biopsy System Acutiy Universal Cutter Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Connecta PE Lines SAVI Prep Device SAVI Spacer Adjustable Biopsy Port Seal BPS-A Prelude Short Sheath Introducer basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Aspira Peritoneal Drainage System EvenMore Chronic Hemodialysis Catheter Revolution Catheter Securement Dev. Merit Drainage Depot Impress and Impress Legato Hydrophilic Angiographic Catheter K08 Fluid Management Kit K04 - Tubing Kit Quick Silver Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit Hydrophilic Prelude SNAP Splittable Sheath Introducer Embosphere Microspheres Emboshpere PRO K16 Microcatheter Kit Merit HeRO Graft HeRO Graft HeartSpan Steerable Sheath Introducer Hydrophilic Guidewire Elation Pulmonary Balloon ER2 Saturate Mixing System ASAPLP Embolectomy Catheter EsophyX Z+ Device Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System Monarch Syringe Fluid Dispense System Prelude Sheath Introducer TruCut 18Ga Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer Prelude Plastic Jacketed Guide Wire Peritoneal Dialysis Catheter Connector Aspira Pleural Drainage System BioFlo Duramax 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 Squirt Fluid Delivery System ReSolve Dilators Non-vascular tissue dilators Sidecar External Working Channel (FG-1011) SafT Needle Direct Blood Transfer K01 Syringe Kit (1mL Polypropylene) K02 Syringe Kit (multiple K01) 1 mL syringe(Polypropylene) DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Stylette (rod obturator) Low Profile Companion Sheath OneSnare Endovascular Snare System Smart Tip Control Syringe SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Ventrax Delivery System Maestro Microcatheter Merit Administration Set CT Transfer Set Merit Disposal Depot PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device K13 Label Kit EmboGold Microspheres 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 Merit Safety Needle EN Snare Endovascular Snare System Osseoflex SB Steerable Balloon (10Ga) Insufflation Set Brochoalveloar Lavage (BAL) Custom Convenience Kit Aero Tracheo Stent and Delivery System Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M) Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411) Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211) PreludeEASE Hydrophilic Sheath Introducer, 7F ReSolve ConvertX Nephroureteral Stent System Osseoflex SB Straight Balloon (8ga) Aspira Peritoneal Drainage System Concierge Guiding Catheter DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer ProGuide Long Term Hemodialysis Catheter SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. Safeguard Pressure Assisted Dressing (24cm) SCOUT Console and Accessory Cart Careflow Central Venous Catheter SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Temno Original Temno ACT EndoMAXX Guidewire Introducer MAP Torque Device & Introducer Safedraw Blood Sampling System Safeguard Pressure Assisted Device (12cm) Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Duramax AEROmini Tracheobronchial Stent System Vessel Dilator Cuff Implantor K10 Waste Management Kit K10T - Waste Management Kit Tubing, Fluid Delivery Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe Merit HeRO Graft Prelude Sheath Half Size (ACT) Prelude Sheath Introducer Micro Ace Gold Advanced Micro Access System ExxTended Catheter K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit Pressure Tubing DiamondTOUCH Inflation Device and Fluid Dispensing Syringe SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Merit Pursue Microcatheter PinVise Torque Device DriPAD Super Absorbent Pad Physiological Reusable Pressure Transducer Wrapsody Cell-Impermeable Endoprosthesis Merit InQwire® Amplatz Super Stiff Guide Wire Repositional Chest Tube RTT14038MB 5.5 F Worley Advanced LVI Lateral Vein Introducer Flex-Neck Catheter Merit Convenience Kits Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Bath Probe Catheter Connection Cables and Cardia Computer Injectate Sensor Cable Slip-Not Perchik Button Assembly Safety Paracentesis Tray (SPPT) Drainage Tubing SafeGuard Focus Compression Device SafeGuard Focus Cool Device Prelude Sheath Introducer Siege Vascular Plug Roadster Guide Sheath SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System TruCut 14Ga OuTake Catheter Extractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-02-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-11
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-16
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2023-11-08
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2009-06-10
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2008-10-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2017-07-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-04-09
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
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-06-27
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2025-01-22
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-01-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-02-17
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-07-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-07
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-01-19
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2025-12-19
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2015-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-01-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2011-05-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-06-12
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
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2016-08-05
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-07-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-08-20
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-08-08
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2020-11-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2019-04-10
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2003-06-05
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-06-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-10-21
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2020-01-20
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2023-05-19
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-13
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-10-24
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-12-19
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-12-21
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2009-01-06
DQF	Actuator, Syringe, Injector Type	Cardiovascular	Class 2	870.1670	2017-02-17
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2017-02-17
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-10-09
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-06-23
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
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2003-06-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-06-30
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2017-06-30
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-12-18
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2013-12-06
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-04-14
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2026-04-14
OEX	Cardiovascular Catheter Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2018-08-01
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-07
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2019-07-12
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-14
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-12-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-20
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2018-03-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-12-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-04-18
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-09-04
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	2019-10-17
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2018-07-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-07-24
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2006-08-11
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-03-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-07-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-04-05
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-08-05
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2017-02-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-12-11
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-07-27
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2020-09-02
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-02-14
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2014-11-19
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2017-07-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-08-16
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2018-07-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-10-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-09-19
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2010-12-13
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-11-02
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2017-09-08
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2018-08-01
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
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-04-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-17
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2016-09-06
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2016-08-05
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2013-12-05
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Gastroenterology, Urology	Class 2	876.1500	2024-07-31
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-12-07
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2007-12-07
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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-08-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2003-12-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-12-18
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2023-04-04
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-08-01
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2016-11-09
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-07-02
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2017-02-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-04-12
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-01-23
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2012-12-14
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-07
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-11-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-12
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
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-04-18
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2018-08-01
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-01-26
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-10-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-11-19
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2015-07-03
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
OYI	Non-Bronchoscopic Bronchoalveolar Lavage Catheter	Anesthesiology	Class 1	868.6810	2015-12-09
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2011-09-15
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2014-03-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-06-23
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-07-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2020-09-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-09-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-02-17
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2011-05-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2021-01-27
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-09-09
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2011-09-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-02-17
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2016-03-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-25
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2014-12-09
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-12-21
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2018-08-01
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-02-17
DRC	Trocar	Cardiovascular	Class 2	870.1390	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
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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-01-22
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2018-08-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-08-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-08-26
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2017-02-17
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2024-12-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-07
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-15
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
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2015-05-18
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-05-01
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2017-02-17
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2013-06-27
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2023-03-10
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-09-09
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-05-06
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
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-11-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-04-02
ODY	Tunneled Catheter Remover	General Hospital	Class 2	880.5970	2009-02-20

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
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
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

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-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
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
2126666	Lake Region Medical	CHASKA, MN, US
3014620201	BEIJING ZKSK TECHNOLOGY CO., LTD.	beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012536737. Last updated year: 2026. Please use registration number 3012536737 when referencing this establishment in official correspondence.