Chrysalis Intelligence · Sponsors · Argon Medical Devices

Argon Medical Devices

Athens, TX, US · 21 510(k) clearances · 18 recalls

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Total clearances
21
2020-06-03 → 2026-02-23
Last 12 months
4
Product codes
8
Most recent
2026-02-23
Name variants in FDA filings: Argon Medical Devices / Argon Medical Devices, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DYB Introducer, Catheter Class II Cardiovascular 8 2025-12-15
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 4 2026-02-05
MMX Device, Percutaneous Retrieval Class II Cardiovascular 3 2023-09-07
KNW Instrument, Biopsy Class II Gastroenterology, Urology 2 2026-02-23
QEY Mechanical Thrombolysis Catheter Class II Cardiovascular 1 2026-01-20
DTK Filter, Intravascular, Cardiovascular Class II Cardiovascular 1 2024-09-10
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class II General Hospital 1 2023-11-30
KRA Catheter, Continuous Flush Class II Cardiovascular 1 2023-04-10
Safety

Recalls (18)

Class I (serious)
0
Risk of injury / death
Total recalls
18
Currently ongoing
7
Most recent
2025-09-12
DateSeverityStatusRecall # ProductCodeReason
2025-09-12 Class II Ongoing Z-0589-2026 Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicate… — Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/o…
2024-07-02 Class II Ongoing Z-3192-2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3… — Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of …
2024-06-14 Class II Ongoing Z-2638-2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 — Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural d…
2023-06-08 Class II Ongoing Z-2239-2023 Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver… — There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
2022-01-24 Class II Ongoing Z-0563-2022 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" — Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the pr…
2021-10-04 Class II Ongoing Z-0354-2022 SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERC… — Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
2021-07-08 Class II Ongoing Z-2501-2021 Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool… — As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
2020-12-10 Class II Terminated Z-1077-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Intr… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-12-10 Class II Terminated Z-1076-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Intr… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-12-10 Class II Terminated Z-1075-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Intr… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-12-10 Class II Terminated Z-1074-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Intr… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-12-10 Class II Terminated Z-1073-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introdu… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-12-10 Class II Terminated Z-1072-2021 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Intro… — Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stre…
2020-06-19 Class II Terminated Z-2806-2020 ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introd… — Sterile introducer sheath set manufactured under one lot with different expiration dates.
2020-04-26 Class II Terminated Z-2109-2020 Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: Th… — Tungsten coils of the guidewire included in the introducer kit were detaching.
2020-04-08 Class II Terminated Z-1938-2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The intr… — Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The…
2020-04-08 Class II Terminated Z-1937-2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters… — Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The…
2020-04-08 Class II Terminated Z-1936-2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheter… — Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The…
Filings

All 510(k) clearances (21)

Date K-number Device Code Class Specialty
2026-02-23 K252795 ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial KNW Class II Gastroenterology, Urology
2026-02-05 K260028 CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister QEW Class II Cardiovascular
2026-01-20 K251318 VariFuse Adjustable Infusion Catheter QEY Class II Cardiovascular
2025-12-15 K253741 V•Stick™ Vascular Access Set DYB Class II Cardiovascular
2024-09-10 K242612 Option ELITE Vena Cava Filter System (352506070E 352506100E) DTK Class II Cardiovascular
2024-08-01 K241145 TLAB® Transvenous Liver Biopsy System (TF-18C) DYB Class II Cardiovascular
2024-03-28 K233909 Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister QEW Class II Cardiovascular
2024-01-19 K232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister QEW Class II Cardiovascular
2023-12-08 K233432 10F Sheath and Dilator Set DYB Class II Cardiovascular
2023-11-30 K230669 L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters LJS Class II General Hospital
2023-09-07 K232443 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit MMX Class II Cardiovascular
2023-05-22 K230631 Kodiak™ Dual Port Coaxial Introducer Kit DYB Class II Cardiovascular
2023-04-10 K223176 Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister KRA Class II Cardiovascular
2022-07-01 K213232 NovaCore Semi-Automatic Biopsy Instrument KNW Class II Gastroenterology, Urology
2022-02-24 K211798 Cleaner Plus Thrombectomy System QEW Class II Cardiovascular
2021-12-10 K213638 Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) DYB Class II Cardiovascular
2021-10-14 K213002 SCORPION Portal Vein Access Set DYB Class II Cardiovascular
2021-01-15 K202141 Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set DYB Class II Cardiovascular
2021-01-05 K200963 Halo Single-Loop Microsnare Kit MMX Class II Cardiovascular
2020-12-22 K201489 Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set DYB Class II Cardiovascular
2020-06-03 K200268 Halo™ Single-Loop Snare Kit MMX Class II Cardiovascular
Data source: openFDA · Generated 2026-10-05 10:36 · Last ingest 2026-10-05T14:36:35.667123 · Pipeline: Chrysalis Intelligence