Argon Medical Devices, Inc.
FDA 510(k) & PMA Approved Devices — 18 products
Total Devices18
Categories8
Latest FDA decision2026-02-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | 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 | 2026-02-23 | View |
| 510(k) | K260028 | CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister | QEW | 2026-02-05 | View |
| 510(k) | K251318 | VariFuse Adjustable Infusion Catheter | QEY | 2026-01-20 | View |
| 510(k) | K253741 | V•Stick™ Vascular Access Set | DYB | 2025-12-15 | View |
| 510(k) | K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | DTK | 2024-09-10 | View |
| 510(k) | K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | DYB | 2024-08-01 | View |
| 510(k) | K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister | QEW | 2024-03-28 | View |
| 510(k) | K232679 | Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister | QEW | 2024-01-19 | View |
| 510(k) | K233432 | 10F Sheath and Dilator Set | DYB | 2023-12-08 | View |
| 510(k) | K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | MMX | 2023-09-07 | View |
| 510(k) | 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 | 2023-04-10 | View |
| 510(k) | K211798 | Cleaner Plus Thrombectomy System | QEW | 2022-02-24 | View |
| 510(k) | K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | DYB | 2021-01-15 | View |
| 510(k) | K200963 | Halo Single-Loop Microsnare Kit | MMX | 2021-01-05 | View |
| 510(k) | K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set | DYB | 2020-12-22 | View |
| 510(k) | K200268 | Halo™ Single-Loop Snare Kit | MMX | 2020-06-03 | View |
| 510(k) | K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | MMX | 2019-12-17 | View |
| 510(k) | K160785 | Worker Guidewire | DQX | 2016-12-08 | View |
No matching devices.