ARGON MEDICAL DEVICES INC.

FDA Device Registration & Listing · ATHENS, TX, US · Registration 1625425

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1625425
FEI Number
1625425
Entity Name
ARGON MEDICAL DEVICES INC.
City/State/Country
ATHENS, TX, US
Establishment Address
1445 FLAT CREEK RD., ATHENS, TX 75751, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ARGON MEDICAL DEVICES, INC (Owner Number: 9059795)
Owner / Operator Contact Address
1445 FLAT CREEK ROAD, --, Athens, TX 75751, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 Kits 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 Stopcock 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 Drakon and Sequre Microcatheters 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PPI Hemodialysis Tray (Not A Start/Stop Kit) Gastroenterology, Urology Class 2 876.5820 2016-09-23
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2013-04-18
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2013-04-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-05-11
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2008-03-24
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2019-09-20
OFB Catheter Guide Wire Kit Cardiovascular Class 2 870.1330 2015-09-09
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2020-11-16
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2008-02-06
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2018-04-26
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2018-04-26
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-01-18
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-01-18
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2013-04-18
MMP Cover, Barrier, Protective General, Plastic Surgery Class 2 878.4370 2019-12-10
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-12-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-05
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2015-07-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-07-20
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2013-04-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-02-04
DOX Fluorometer, Lead (Dedicated Instruments) Clinical Toxicology Class 2 862.3550 2008-03-24
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2013-04-18
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-02-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-08-07
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2008-03-24
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2017-10-10
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2006-08-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-09-22
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 1993-01-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-01-18
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2013-04-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-04-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-04-18
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-02-06
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2013-04-18
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2012-01-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-01-18
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2013-04-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2015-08-21
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2016-09-23
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2013-04-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-02-17
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2022-09-28
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2008-04-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-04-18
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-02-06
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2008-02-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-02-04
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-04-28
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2013-04-18
LJE Catheter, Nephrostomy Unknown Class U N/A 2013-04-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-04-18
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2013-04-19
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-02-24
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2022-02-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-10-22
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2016-01-21
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2013-04-18
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2016-07-27
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2018-11-13
MDG System, Intrafallopian Cannula Obstetrics/Gynecology Class 2 884.4530 2013-04-18
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2022-09-28
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2016-01-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2016-01-21
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2021-01-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-01-06
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-10-22
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2008-02-11
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2016-01-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-02-06
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2008-03-24
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-10-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-03-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-09
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2008-03-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2008-03-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-04-22
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2008-03-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-06-14
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-02-04
OJT Aspiration Tray General, Plastic Surgery Class 1 878.4800 2015-07-30
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-08-07
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-12-08
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2017-10-10
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2012-03-27
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-02-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-02-06
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2007-04-24
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2023-11-02
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2013-04-19
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2008-02-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2021-01-29
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2021-01-29
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-09-28
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2014-11-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-09
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2015-08-03
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2012-04-09
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2016-07-27
HXD Clamp General, Plastic Surgery Class 1 878.4800 2008-06-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-05-26
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-04-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2008-02-06
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2017-10-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-12-09
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2008-02-06
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2015-02-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-12-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2021-01-29
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-04-18
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-01-18
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2011-07-21
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2013-04-18
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2013-04-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-02-06
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-01-18

Official Correspondent

Scott Bishop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARGON MEDICAL DEVICES, 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
1417485 ARGON MEDICAL DEVICES, INC. WHEELING, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973037 Avid N.I.T., Inc. N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 1998-01-27
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-2012 Worldwide Medical Technologies, LLC 1
Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2017 Merit Medical Systems, Inc. 2
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1625425. Last updated year: 2026. Please use registration number 1625425 when referencing this establishment in official correspondence.
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