Company · US
Argon Medical Devices, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (4 in 12 months)
137recalls (9 in 12 months)
109recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 54 |
| FTN | Plastic Surgery And Accessories Kit | 19 |
| DYB | Introducer, Catheter | 17 |
| KNW | Instrument, Biopsy | 13 |
| DRS | Transducer, Blood-Pressure, Extravascular | 9 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 7 |
| IZI | System, X-Ray, Angiographic | 6 |
| KGC | Tube, Gastro-Enterostomy | 6 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 5 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 |
| MMX | Device, Percutaneous Retrieval | 4 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 4 |
| DTK | Filter, Intravascular, Cardiovascular | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 3 |
| KRA | Catheter, Continuous Flush | 2 |
| DSK | Computer, Blood-Pressure | 1 |
| GCB | Needle, Catheter | 1 |
| GDR | Saw, Manual And Accessories | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| OEZ | Cardiovascular Procedure Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2026 | K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Argon Medical Devices, Inc. | KNW |
| Feb 5, 2026 | K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister Argon Medical Devices, Inc. | QEW |
| Jan 20, 2026 | K251318 | VariFuse Adjustable Infusion Catheter Argon Medical Devices, Inc. | QEY |
| Dec 15, 2025 | K253741 | VStick Vascular Access Set Argon Medical Devices, Inc. | DYB |
| Sep 10, 2024 | K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) Argon Medical Devices, Inc. | DTK |
| Aug 1, 2024 | K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) Argon Medical Devices, Inc. | DYB |
| Mar 28, 2024 | K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Macerati Argon Medical Devices, Inc. | QEW |
| Jan 19, 2024 | K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister Argon Medical Devices, Inc. | QEW |
| Dec 8, 2023 | K233432 | 10F Sheath and Dilator Set Argon Medical Devices, Inc. | DYB |
| Nov 30, 2023 | K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters Argon Medical Devices | LJS |
| Sep 7, 2023 | K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc. | MMX |
| May 22, 2023 | K230631 | Kodiak Dual Port Coaxial Introducer Kit Argon Medical Devices | DYB |
| Apr 10, 2023 | K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Argon Medical Devices, Inc. | KRA |
| Jul 1, 2022 | K213232 | NovaCore Semi-Automatic Biopsy Instrument Argon Medical Devices | KNW |
| Feb 24, 2022 | K211798 | Cleaner Plus Thrombectomy System Argon Medical Devices, Inc. | QEW |
| Dec 10, 2021 | K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga N Argon Medical Devices | DYB |
| Oct 14, 2021 | K213002 | SCORPION Portal Vein Access Set Argon Medical Devices | DYB |
| Jan 15, 2021 | K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set Argon Medical Devices, Inc. | DYB |
| Jan 5, 2021 | K200963 | Halo Single-Loop Microsnare Kit Argon Medical Devices, Inc. | MMX |
| Dec 22, 2020 | K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Po Argon Medical Devices, Inc. | DYB |
| Jun 3, 2020 | K200268 | Halo Single-Loop Snare Kit Argon Medical Devices, Inc. | MMX |
| Dec 17, 2019 | K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc. | MMX |
| Dec 8, 2016 | K160785 | Worker Guidewire Argon Medical Devices, Inc. | DQX |
| Dec 19, 2014 | K141969 | FIRSTSTIC N INTRODUCER Argon Medical Devices, Inc. | DYB |
| Mar 29, 2007 | K070384 | ARGON CONTINUOUS FLUSH DEVICE Argon Medical Devices, Inc. | KRA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2026 | Argon Medical Devices, Inc L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 Open, Classified |
LJS | K230669 |
| Jul 24, 2026 | Argon Medical Devices, Inc L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1. Open, Classified |
LJS | K230669 |
| Jul 10, 2026 | Argon Medical Devices, Inc Bone Marrow Tray, REF: CB0033TL; CB0355TLA Open, Classified |
KNW | K980196 |
| Jul 10, 2026 | Argon Medical Devices, Inc Arterial Line Kit 20ga x 6, REF: 400115A Open, Classified |
GDY | K780871 |
| Jul 10, 2026 | Argon Medical Devices, Inc T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL Open, Classified |
KNW | K980196 |
| Jul 10, 2026 | Argon Medical Devices, Inc General Biospy Tray, REF: GUTS1000 Open, Classified |
KNW | K980196 |
| Jul 10, 2026 | Argon Medical Devices, Inc One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular Open, Classified |
DRE | K780126 |
| Jul 10, 2026 | Argon Medical Devices, Inc Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A Open, Classified |
OEZ | None listed |
| Nov 24, 2025 | Argon Medical Devices, Inc Option"ELITE Vena Cava Filter System REF 352506070E
UDI-DI code: 00886333217151
The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placemen Open, Classified |
DTK | K133243 |
| Sep 20, 2024 | Argon Medical Devices, Inc BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370 Open, Classified |
KNW | K904987 K982960 |
| Aug 16, 2024 | Argon Medical Devices, Inc L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 Open, Classified |
LJS | K230669 |
| Jul 27, 2023 | Argon Medical Devices, Inc Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797 Open, Classified |
DTK | K133243 |
| Jan 24, 2022 | Argon Medical Devices, Inc 1. Arterial Line Kit 20ga x 6"
2. Arterial Line Kit /1 20ga x 6" Open, Classified |
GDY | K780871 |
| Oct 4, 2021 | Argon Medical Devices, Inc SuperCore Biopsy Instrument:
REF/Product Description:
701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM;
701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM;
701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM;
701118060 Open, Classified |
KNW | K974814 |
| Jul 8, 2021 | Argon Medical Devices, Inc Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. Open, Classified |
DYB | K202141 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight ca Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, Terminated |
DYB | K022634 |
| Dec 10, 2020 | Argon Medical Devices, Inc Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Cat Terminated |
DYB | K022634 |
| Jun 19, 2020 | Argon Medical Devices, Inc ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits bui Terminated |
DRE | K780126 |
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO Terminated |
DQX | K160785 |
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO Terminated |
DQX | K160785 |
| Apr 26, 2020 | Argon Medical Devices, Inc Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle pu Terminated |
GCB | None listed |
| Apr 8, 2020 | Argon Medical Devices, Inc PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percut Terminated |
GDY | K780126 |
| Apr 8, 2020 | Argon Medical Devices, Inc Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressur Terminated |
GDY | K780871 |
| Apr 8, 2020 | Argon Medical Devices, Inc Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressu Terminated |
GDY | K780871 |
| Dec 2, 2019 | Argon Medical Devices, Inc BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to o Terminated |
KNW | K904987 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | K810637 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | K820883 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medic Terminated |
DRS | None listed |
| Oct 16, 2018 | Argon Medical Devices, Inc (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx;
(2) Argon Medical Devices Vascuclamp, Rad Terminated |
DRS | K771701 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | K810637 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | K810637 |
| Oct 16, 2018 | Argon Medical Devices, Inc (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx;
(2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, S Terminated |
DRS | K780271 |
| Oct 16, 2018 | Argon Medical Devices, Inc Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX. Terminated |
DRS | K810637 |
| Oct 16, 2018 | Argon Medical Devices, Inc (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and
(2) Argon Medical Devices Double Male LL Adapter, Terminated |
DRS | K810637 |
| May 11, 2017 | Argon Medical Devices, Inc Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4
Usage:
Argon Arterial Access Need Terminated |
GDR | None listed |
| Feb 13, 2017 | Argon Medical Devices, Inc HARVEST NEEDLE 15GA X 2
Intended for the purpose of harvesting bone and/or bone marrow specimens Terminated |
KNW | K980196 |
| Feb 13, 2017 | Argon Medical Devices, Inc T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN
Intended for the purpose of harvesting bone and/or bone marrow specimens Terminated |
KNW | K980196 |
| Feb 13, 2017 | Argon Medical Devices, Inc BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX
Intended for the purpose of harvesting bone and/or bone marrow specimens Terminated |
KNW | K980196 |
| Oct 7, 2016 | Argon Medical Devices, Inc MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.
A sheath used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | K071574 |
| Mar 1, 2016 | Argon Medical Devices, Inc ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.
Indicated for use in arterial and venous procedures r Terminated |
DRE | K780126 |
| Jul 21, 2015 | Argon Medical Devices, Inc T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1 Terminated |
KNW | K980196 |
| Jul 21, 2015 | Argon Medical Devices, Inc Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI Terminated |
KNW | None listed |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm)
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a Terminated |
MSD | K023847 K102043 |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a c Terminated |
MSD | K023847 K102043 |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Terminated |
MSD | K023847 K102043 |
| Jul 6, 2012 | Argon Medical Devices, Inc Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028.
The Terminated |
DSK | K885235 |
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