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Argon Medical Devices, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories8
Latest Approval2026-02-23
TypeNumberDevice NameCodeDate
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