Argon Medical Devices, Inc

FDA Regulatory Profile

Summary

Total Recalls
42 (2 Class I)
510(k) Clearances
25
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0589-2026Class IIOption"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITSeptember 12, 2025
Z-3192-2024Class IIBioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-158July 2, 2024
Z-2638-2024Class IIL-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539June 14, 2024
Z-2239-2023Class IIArgon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of JugulaJune 8, 2023
Z-0563-2022Class II1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"January 24, 2022
Z-0354-2022Class IISuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9COctober 4, 2021
Z-2501-2021Class IIScorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide aJuly 8, 2021
Z-1076-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore BiopDecember 10, 2020
Z-1075-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore BiopDecember 10, 2020
Z-1074-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore BiopDecember 10, 2020
Z-1077-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore BiopDecember 10, 2020
Z-1072-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore BiopsDecember 10, 2020
Z-1073-2021Class IIArgon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore BiopsDecember 10, 2020
Z-2806-2020Class IIClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - PJune 19, 2020
Z-2109-2020Class IISkater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079April 26, 2020
Z-1937-2020Class IIArterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product UsageApril 8, 2020
Z-1938-2020Class IIPAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - ProApril 8, 2020
Z-1936-2020Class IIArterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product UsagApril 8, 2020
Z-1792-2020Class I0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)208863330080December 4, 2019
Z-1791-2020Class I0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)2088633330080December 4, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm witFebruary 23, 2026
K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac AspiFebruary 5, 2026
K251318VariFuse Adjustable Infusion CatheterJanuary 20, 2026
K253741V•Stick™ Vascular Access SetDecember 15, 2025
K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)September 10, 2024
K241145TLAB® Transvenous Liver Biopsy System (TF-18C)August 1, 2024
K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F HanMarch 28, 2024
K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro AspiJanuary 19, 2024
K23343210F Sheath and Dilator SetDecember 8, 2023
K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersNovember 30, 2023
K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitSeptember 7, 2023
K230631Kodiak™ Dual Port Coaxial Introducer KitMay 22, 2023
K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 6April 10, 2023
K213232NovaCore Semi-Automatic Biopsy InstrumentJuly 1, 2022
K211798Cleaner Plus Thrombectomy SystemFebruary 24, 2022
K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS0December 10, 2021
K213002SCORPION Portal Vein Access SetOctober 14, 2021
K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetJanuary 15, 2021
K200963Halo Single-Loop Microsnare KitJanuary 5, 2021
K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, TraveDecember 22, 2020