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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemodialysis Tray (Not A Start/Stop Kit) | PPI | Class 2 | Gastroenterology, Urology | No | 2016-09-23 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2013-04-18 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2013-04-18 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2017-05-11 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2008-03-24 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2019-09-20 |
| Catheter Guide Wire Kit | OFB | Class 2 | Cardiovascular | No | 2015-09-09 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2020-11-16 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2008-02-06 |
| Dilator, Urethral | KOE | Class 2 | Gastroenterology, Urology | No | 2018-04-26 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2018-04-26 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2012-01-18 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2012-01-18 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2013-04-18 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2019-12-10 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2024-12-05 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-12-05 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2015-07-30 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-07-20 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2013-04-18 |
| Fluorometer, Lead (Dedicated Instruments) | DOX | Class 2 | Clinical Toxicology | No | 2008-03-24 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2013-04-18 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2008-02-06 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2008-03-24 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2017-10-10 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2006-08-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2016-09-22 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 1993-01-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-04-18 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2013-04-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-04-18 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2008-02-06 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-04-18 |
| Bag, Bile Collecting | EXF | Class 2 | Gastroenterology, Urology | No | 2013-04-18 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2012-01-24 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2013-04-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2015-08-21 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2016-09-23 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2008-04-19 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2011-04-28 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2013-04-18 |
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2016-01-21 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2013-04-18 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2016-07-27 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2018-11-13 |
| System, Intrafallopian Cannula | MDG | Class 2 | Obstetrics/Gynecology | No | 2013-04-18 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-01-06 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2008-02-11 |
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2008-03-24 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2025-12-09 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2008-03-24 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2008-03-24 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2013-04-22 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2008-03-24 |
| Aspiration Tray | OJT | Class 1 | General, Plastic Surgery | No | 2015-07-30 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2024-08-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-10-10 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2012-03-27 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2007-04-24 |
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2008-02-06 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2014-11-13 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2015-08-03 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2012-04-09 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2008-06-13 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2015-02-17 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2011-07-21 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2013-04-18 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2013-04-18 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2016-12-01 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2013-04-22 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2005-09-19 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2008-04-19 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2013-04-18 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2012-03-27 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2006-08-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-07-30 |
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