FDA Registration Active 🇺🇸 United States

ARGON MEDICAL DEVICES INC.

Reg #: 1625425 · FEI: 1625425 · Expires 2026
Products
76
Proprietary Names
197
Establishment Types
4
Classifications
76

Registration Details

Registration Name
ARGON MEDICAL DEVICES INC.
Registration Number
1625425
FEI Number
1625425
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1445 FLAT CREEK RD.
City
ATHENS
State
TX
ZIP
75751
Country
US

Regulatory Submissions

510(k) Number
K944522

Owner / Operator

Firm Name
ARGON MEDICAL DEVICES, INC
Operator Number
9059795
Address
1445 FLAT CREEK ROAD, --
City
Athens
State
TX
Postal Code
75751
Country
US
Correspondent
Scott Bishop

Products

Device Name Product Code
Hemodialysis Tray (Not A Start/Stop Kit) PPI
System, Applicator, Radionuclide, Manual IWJ
Catheter, Continuous Irrigation GBQ
Introducer, Catheter DYB
Tubing, Fluid Delivery FPK
Wire, Guide, Catheter, Exempt PTL
Catheter Guide Wire Kit OFB
Device, Percutaneous Retrieval MMX
Clamp, Surgical, General & Plastic Surgery GDJ
Dilator, Urethral KOE
Syringe, Balloon Inflation MAV
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Needle, Catheter GCB
Cover, Barrier, Protective MMP
Peripheral Mechanical Thrombectomy With Aspiration QEW
Catheter, Continuous Flush KRA
Nerve Block Tray OGJ
Wire, Guide, Catheter DQX
Needle, Aspiration And Injection, Reusable GDM
Fluorometer, Lead (Dedicated Instruments) DOX
Marker, Radiographic, Implantable NEU
Clamp, Vascular DXC
Gauze/Sponge, Internal, X-Ray Detectable GDY
Dilator, Catheter GCC
Guide, Needle, Surgical GDF
Set, Administration, Intravascular FPA
Needle, Biopsy, Cardiovascular DWO
Needle, Aspiration And Injection, Disposable GAA
Stents, Drains And Dilators For The Biliary Ducts FGE
Needle, Hypodermic, Single Lumen FMI
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Instrument, Biopsy KNW
Bag, Bile Collecting EXF
Peripheral Catheter Insertion Kit OWL
Cannula, Manipulator/Injector, Uterine LKF
Container, Specimen, Sterile FMH
Cardiovascular Procedure Kit OEZ
Dilator, Vessel, For Percutaneous Catheterization DRE
Stopcock, I.V. Set FMG
Catheter, Nephrostomy LJE
Filter, Intravascular, Cardiovascular DTK
Catheter, Nephrostomy, General & Plastic Surgery GBO
Catheter, Peripheral, Atherectomy MCW
Drape, Surgical, Antimicrobial KKX
System, Intrafallopian Cannula MDG
Catheter, Percutaneous DQY
Catheter, Flow Directed DYG
Tube, Gastro-Enterostomy KGC
Catheter, Intravascular, Diagnostic DQO
Accessories, Blood Circuit, Hemodialysis KOC
System, X-Ray, Angiographic IZI
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Probe, Thermodilution KRB
Aspiration Tray OJT
Cannula, Surgical, General & Plastic Surgery GEA
Tape And Bandage, Adhesive KGX
Intravenous Extension Tubing Set OJA
Blade, Scalpel GES
Transducer, Blood-Pressure, Extravascular DRS
Percutaneous Sheath Introducer Kit OFL
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Catheter, Hemodialysis, Implanted MSD
Clamp HXD
Biopsy Needle FCG
Device, Biopsy, Endomyocardial DWZ
Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
Splint, Intranasal Septal LYA
Label Or Tag, Sterile LYV
Accessories, Catheter KGZ
Basin, Emesis FNY
Trocar DRC
Accessories, Catheter, G-U KNY
Angiography/Angioplasty Kit OEQ
Injector And Syringe, Angiographic DXT
Guide, Surgical, Instrument FZX

Proprietary Names

Kits Prostate Stablization Needles Prostate Seeding Sets Skater Single Step Drainage Catheter Skater Drainage Catheter Skater Centesis Catheter Skater All Purpose Drainage Catheter Skater All Purpose and Nephrostomy Drainage Catheter Skater Mini-Loop V-Stick Argon Central Venous Catheter Tray Guidewire Torque Handle Halo Bulldog VascuClamps EKM Inflation Device Skater Introducer Sets Cleaner Plus 18F Myelogram Tray Arthrogram Tray Lumbar Puncture Tray Bracco Arthrogram Tray Bracco Local Anesthesia Tray Mandrel Guidewire Hawkins III Breast Localization Needle w/ Hardware Hawkins II Breast Localization Needles w/ Flexstrand Hawkins II Breast Localization Needle w/ Hardware Hawkins III Breast Localization Needle w/ Echogenic Tip and Hardwire Hawkins I Breast Localization Needles Hawkins III Breas Localization Needle w/ Flexstrand Argon Guidewires Argon Heparin Coated Guidewires Argon PTFE Coated Stainless Steel Guidewires Argon Stainless Steel Guidewires V-Mark Breast Biopsy Marker Mini Bulldog TLAB® Transvenous Liver Biopsy System Argon Arterial Catheter Kit Accessories to Drainage Catheter Drainage Catheter Argon Arterial Needle Biopsy Needles First PICC SL Kit D Wire Breast Localization Needles Accura II Breast Localization Needles (Sadowsky Style) Accura Breast Localization Needles Skater Billiary Drainage Catheter Galactography Kits Argon High Pressure Stopcock Super Core II Biopsy Instruments D-Bag Drainage Bag Tru-Core II URO Automatic Biopsy Instruments First Midcath SL Kit HSG Catheters, HSG Procedure Tray Co-Axial Introducer Needle Abrivo Introducer Specimen Container Atrieve Vascular Snare Kit T-Lab AVI Dual Lumen HydroPICC BioPince Full Core Biopsy Instrument BioPince Ultra Full Core Biopsy Instrument Argon Tuohy-Borst Introducer Argon Sheath/Dilator Argon Hemostasis Introducer Argon One-Piece Introducer V-Stick Vacular Access Set Argon Modified Disposable Stopcock Argon Stopcock Argon Continuous Flush Device Pro-Mag Ultra 2.2 Automatic Biopsy Instrument Pro-Mag Ultra Biopsy Needles, Pro-Mag Ultra Automatic Biopsy Instrument Stopcock 3 Way Screw Dilator Homer Breast Localization Needles Microlite Disposable Suction Needle Access needles Co-axial Introducer Needles 11 guage Bone Access Needles Cleaner Plus™ Thrombectomy System Hawkins Blunt Needles Skater Nephrostomy Drainage Catheter w/ Locking Pigtail IMC Drapes Hystero-Access Catheter Set (a.k.a. PBN Fallopian Tube Catheter System) Uterine Cornual Access Set (Tungsten) AVI HydroPICC Halo Single-Loop Microsnare Argon Septishield Argon Obturator Central Catheter Tray Worker Guidewire Drakon and Sequre Microcatheters Argon Control & Med Syringes Bone Marrow Harvest Needles Bone Marrow Aspiration Needles T-Lok Bone Marrow Biopsy Needles OSTY-CORE BONE BIOPSY NEEDLES Pediatric Bone Marrow Access Needles Bone Marrow Biopsy Trays MANAN SPINAL AND EPIDURAL NEEDLES Manan Spinal Needles Safewedge Relief Valve Device Kodiak Dual Port Coaxial Introducer Kit Steriflo II Argon Bone Marrow Tray Bracco Basic Biopsy Tray Argon Soft Tissue Biopsy Tray Introducer Cannula / Needle IntraCath Skin Fix Tubing Vessel Loops Thermodilution Catheter Argon Medical Scalpels Short/Long Handles Locking Syringe ArgoTrans Traveler38 Portal Vein Access Set Traveler21 Portal Vein Access Set Traveler16 Portal Vein Access Set AVI HydroMID MicroStic OneStic Drakon® and Sequre® Microcatheters Amniocentesis needle and accessories Ultrastream Argon Towel Clamp ACN, SACN, Biopsy Needle Pointer Nitinol Guidewire Westcott Soft Tissue Biosy Needles Franseen Trocar MaxiCELL Green Turner Fine Needle Aspiration (FNA) Biopsy Needles Chiba Spinal Pro-Cut Vessel Paws F/F Luer Adaptor M/M Luer Adaptor Zero Port Argon Angiography Drape SABD Scorpion Scorpion X Tru-Core III Semi-Automatic Biopsy Instruments First PICC DL Kit Device, Biopsy, Endomyocardial JAWZ V-Pad Argon Introducer for Guiding Cath Safety MST Kit MLK Identification Labels Single-Loop Snare Retrieval Kit Triple-Loop Snare Retieval Kit Argon High Pressure Lines Splittable Needle Introducer First Midcath First PICC Coaxial Access System Hard Introducer (6 & 11cm) Coaxial Access System Soft Introducer (10, 13 & 23cm) Peritoneal Lavage drainage needle/catheter Connecting tubes for drainage catheters Catheter securement device SKATER Fix Argon Vessel Dilator Guidewire Bowl Tru-Core I EURO Biopsy Needles Tru-Core Auto Biopsy Needles Techna-Cut Biopsy Needle V-Stick Vacular Access Set with Talwire Ultra-Core Biopsy Needles Argon Percutaneous Needle Argon Cournand Needle Vessel Clude Vessel Paw Worker Guidewire Standard Worker Guidewire Amplatz Argon EKM Inflation Device Guidewire Introducer Needle/ Winged Base Plate Guidewire Introducer Needle Seldinger Needle Guidewires Potts/Cournand Needle SuperCore Advance convenience kit L-Cath™ Midline Catheters L-Cath™ Single and Dual Lumen Catheters Argon Pressure Monitoring Lines CleanerVac Thrombectomy System HBO Pass Through Argon Medical IV Lines ARGON ANGIO FLUSHING SET Argon Fluid Management System ArgoBags Needle Guide

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility