Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033589330

FEI Number

3033589330

Entity Name

Merit Medical Australia Pty Ltd.

City/State/Country

Braiside Victoria, AU

Establishment Address

53 Canterbury Road, Braiside Victoria 3195, AU

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Merit Hydrophilic Guide Wire Ventrax Delivery System TruCut 18Ga MultiPlex II Controller Activation Element, ERx bone cement Aerosizer Impress UAC Catheter K08 Fluid Management Kit K04 - Tubing Kit Pinvise Torque Device SeaDragon Torque Device HeartSpan Steerable Sheath Introducer DriPAD Super Absorbent Pad InQwire Amplatz Super Stiff Guide Wire AEROmini Tracheobronchial Stent System STATSEAL WOUNDSEAL DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Prelude Sheath Introducer PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK SPINR High-Performance Guidewire Catheter VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston Transpedicular Drill Preston Hard Bone Introducer Preston Long Drill MiniStop Filter Closed Waste Basin Merit Pursue Microcatheter Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Torpedo Gelatin Foam Maestro Microcatheter Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer SCOUT Console and Accessory Cart Osseoflex SB Steerable Balloon (10Ga) Dash 9F Hydrophilic Sheath Introducer 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 Pressure Tubing Squirt Fluid Delivery System Merit Drainage Depot Peritoneal Dialysis Catheter Connector Aspira Peritoneal Drainage System Stylette (rod obturator) SCOUT Bx Delivery System Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Temno Original Temno ACT Novatome Endomyocardial Biopsy Forceps K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter Duramax ClariVein IC Infusion Catheter EvenMore Chronic Hemodialysis Catheter Merit Syringe Insufflation Set ARC Catheter Osseoflex SB Steerable Balloon (8ga) Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. PreludeEASE Hydrophilic Sheath Introducer, 7F Temno Evolution Critiflo Disposable Diaphragm Dome Rad Rest Flex-Neck Infant Catheter PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Connecta PE Lines StabiliT Introducer and Delivery Instruments Maxxwire EN Snare Endovascular Snare System VACLOK Syringe K02 Syringe Kit (multiple K01) TruCut 14Ga S-MAK XL 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 Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Fountain ValveTip Infusion Catheter BowTie Guide Wire Insertion Device Spectraject Control Syringe Merit Administration Set CT Transfer Set Impress and Impress Legato Hydrophilic Angiographic Catheter Aero DV Tracheobronchial Stent System Hydrophilic Guidewire K10 Waste Management Kit K10T - Waste Management Kit Roadster Guide Sheath ROSE Critikit Plus In-Line Room/ Ice Injectate ASAPLP Embolectomy Catheter SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces Prelude Short Sheath Introducer Careflow Central Venous Catheter Surfacer Inside-Out Access Catheter System SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Merit Convenience Kits 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 Prelude Wave Hydrophilic Sheath Introducer Intellisystem Inflation Device Fluid Dispensing Syringe Prelude Prestige Splittable Sheath Introducer SAVI Applicator Kit Merit 1mL Syringe (COP) Flex-Neck Extender/Repair Kit Corvocet Biopsy System TRAM-P TRAM C2 Cryoballoon Ablation System Secalon T Catheter Merit HeRO Graft K13 Label Kit ReSolve Biliary Locking Drainage Catheter Temno Elite Biopsy Systems SwiftNINJA Microcatheter HeartSpan Steerable Introducer Sheath Prelude SNAP Splittable Sheath Introducer ER2 Saturate Mixing System HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Finale Radial Compression System RADstat Radial Artery Compression Device Vessel Dilator DiamondTOUCH Inflation Device and Fluid Dispensing Syringe DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer SwiftNINJA Steerable Microcatheter Aspira Pleural Drainage System Pressure Infusor Bags (PIB) Aspira Peritoneal Drainage System K14 Dialysis Kit Aero Tracheo Stent and Delivery System Concierge Guiding Catheter PreludeSYNC EZ Radial Compression Device SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Osseoflex SB Straight Balloon (8ga) Maestro Microcatheter Merit PAK Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Safety Paracentesis Tray (SPPT) Drainage Tubing EmboGold Microspheres Corvocet Coaxial Introducer Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Impress with Legato Hydrophilic Coating Miser Contrast Management System basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Safedraw Blood Sampling System SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Performa Diagnostic Intravascular Catheter Preston Transpedicular Introducer Preston Hard Bone Access Needle with Drill Preston Bone Filler InQwire Diagnostic (Support) Non-Vascular Guide Wire Maestro Microcatheter Prelude IDeal Hydrophilic Sheath Introducer Tubing, Fluid Delivery Safeguard Pressure Assisted Device (12cm) Guidewire with Palladium Tip Micro Ace Gold Advanced Micro Access System Faller Trocar Wrapsody Cell-Impermeable Endoprosthesis Prelude Sheath Half Size (ACT) Prelude Sheath Introducer Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Micro Plug Set Aspira Pleural Drainage System QuadraSphere Q2 Microspheres QuadraSphere Microspheres Thoracentesis Tray (TAPS) Universal Coaxial Needles HeRO Graft Alimaxx E Exacta Percutaneous Sheath Introducer InQwire Guidewires Repositional Chest Tube RTT14038MB Merit Disposal Depot Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit ReSolve Dilators Non-vascular tissue dilators DuraFlow 2 Hemodialysis Catheter K16 Microcatheter Kit RXP (Rapid Exchange Flushing Syringe) Bath Probe Catheter Connection Cables and Cardia Computer Injectate Sensor Cable Aspira Peritoneal Drainage System Sidecar External Working Channel (FG-1011) Elation Pulmonary Balloon InQwire Merit InQwire® Amplatz Super Stiff Guide Wire FlowGuard Micro Ace Advanced Micro Access System Embedding Tool Corvocet Biopsy System ReSolve ConvertX Biliary Stent System Merit Safety Needle InQwire Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) BioSentry Tract Sealant System SafeGuard Focus Compression Device SafeGuard Focus Cool Device Resilience Fully Covered Esophageal Stent System 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 OuTake Catheter Extractor OneSnare Endovascular Snare System CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter One-Vac Evacuated Drainage Bottle VacLok AT Syringe C2 Cryoballoon Endogrip Elation Pulmonary Balloon 4mm Osseoflex SB Straight Balloon (10ga) Revolution Catheter Securement Dev. Safeguard Radial Compression Device Brochoalveloar Lavage (BAL) Custom Convenience Kit ReSolve ConvertX Nephroureteral Stent System Sterilized Convenience Kits S-MAK Meritrans Disposable Transducer Acutiy Universal Cutter Mighty Wire H20 Guidewire 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 Low Profile Companion Sheath Fountain 4F Catheter & Occluding GW SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-06-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-12
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2016-08-05
FDY	Device, Measuring, For Panendoscope	Gastroenterology, Urology	Class 1	876.1500	2009-06-11
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-08-08
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2018-07-17
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2017-07-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-04-06
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2015-08-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-03-06
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2014-12-09
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-06-02
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2017-03-01
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-10-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-01-13
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-08-05
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2013-12-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-02
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-05-01
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-01-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-09-05
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2003-12-18
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2021-01-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2017-07-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-10
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-07-14
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2016-11-09
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2017-07-24
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	2018-03-15
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-08-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-07
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2025-01-22
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2018-08-01
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2003-06-05
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-01-18
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-02-10
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-12-21
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
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-04-18
DRC	Trocar	Cardiovascular	Class 2	870.1390	2007-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-06-23
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-03-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-10-24
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2018-04-18
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2017-02-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-06-11
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2015-07-03
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-04-02
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2019-04-10
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-08-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-05-25
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-07
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-09-04
DQF	Actuator, Syringe, Injector Type	Cardiovascular	Class 2	870.1670	2017-02-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-08-16
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2009-06-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-17
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2018-08-01
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
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2017-02-17
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2013-12-05
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-01-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-12-11
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
QJH	Reverse Central Venous Recanalization System	Cardiovascular	Class 2	870.1342	2025-12-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-01-17
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2015-05-18
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2016-08-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-05
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2006-08-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-09-12
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2018-07-19
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-11-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-10-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-22
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-03-13
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
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2026-05-08
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
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
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2018-08-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-12-02
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-12-08
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2016-11-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-04-14
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2016-08-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-02-19
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2003-06-05
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-07
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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-02-17
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-07-22
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2023-10-18
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2003-12-18
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2020-09-02
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2018-08-01
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2011-09-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-09-19
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-01-25
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-11-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
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
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2023-03-10
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-01-26
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2015-08-20
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2007-12-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-10-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-04-12
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-07-27
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-02-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-08-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-12-21
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-08
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2009-01-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-02-15
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-02-17
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2016-03-30
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2009-11-09
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
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	2023-11-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-08-05
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-12-14
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2023-04-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-09-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-09-08
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-09-08
PXI	Thoracentesis Tray	General Hospital	Class 2	880.5570	2023-05-19
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-03-27
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
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-06-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-02-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-12-16
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2017-11-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-07-27
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2014-07-02
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-06-08
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2018-08-01
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-12-18
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2017-02-17
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2020-09-02
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2016-09-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-07-31
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-10-09
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-28
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	2014-11-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-10-17
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-16
OMT	Absorbable Lung Biopsy Plug	General, Plastic Surgery	Class 2	878.4755	2023-06-08
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-09-09
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2025-07-24
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2013-11-11
ODY	Tunneled Catheter Remover	General Hospital	Class 2	880.5970	2009-02-20
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2012-12-14
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-06-19
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2021-06-23
PUR	Vacuum Syringe	General Hospital	Class 2	880.5860	2017-07-28
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2026-05-08
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-03-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-27
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-27
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2006-02-14
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2013-10-25
OYI	Non-Bronchoscopic Bronchoalveolar Lavage Catheter	Anesthesiology	Class 1	868.6810	2015-12-09
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-07-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-11
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-03-15
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2007-12-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-01-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-10-14
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2014-11-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-01-23
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2007-12-07
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2007-12-07
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-09-09

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

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3024743081	EMBRACE MEDICAL LTD.	Tel Aviv, IL
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3018070217	SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD.	Suzhou Jiangsu, CN
3015522130	NANO4IMAGING USA, LLC.	Dublin, OH, US
3007635982	Confluent Medical Technologies, Inc	Fremont, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033589330. Last updated year: 2026. Please use registration number 3033589330 when referencing this establishment in official correspondence.