FDA 510(k) Applications Submitted by ARGON MEDICAL DEVICES, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K201489 06/04/2020 Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set Argon Medical Devices, Inc.
K202141 07/31/2020 Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set Argon Medical Devices, Inc.
K200268 02/03/2020 HaloÖ Single-Loop Snare Kit Argon Medical Devices, Inc.
K200963 04/10/2020 Halo Single-Loop Microsnare Kit Argon Medical Devices, Inc.
K211798 06/10/2021 Cleaner Plus Thrombectomy System Argon Medical Devices, Inc.
K232443 08/14/2023 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc.
K232679 09/01/2023 CleanerÖ Pro Thrombectomy System; CleanerÖ Pro Aspiration Catheter with Handpiece; CleanerÖ Pro Aspiration Canister Argon Medical Devices, Inc.
K223176 10/11/2022 Cleaner PlusÖ Thrombectomy System, Cleaner PlusÖ Aspiration Catheter, Cleaner PlusÖ Handpiece with 65cm Maceration Wire, Cleaner PlusÖ Handpiece with 135cm Maceration Wire, Cleaner PlusÖ Aspiration Canister Argon Medical Devices, Inc.
K233432 10/12/2023 10F Sheath and Dilator Set Argon Medical Devices, Inc.
K233909 12/12/2023 CleanerÖ Plus 18F Thrombectomy System - CleanerÖ Plus 18F Aspiration Catheter, CleanerÖ Plus 18F Handpiece with Maceration Wire, CleanerÖ Plus 18F Aspiration Canister Argon Medical Devices, Inc.
K241145 04/25/2024 TLAB« Transvenous Liver Biopsy System (TF-18C) Argon Medical Devices, Inc.
K191758 07/01/2019 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit Argon Medical Devices, Inc.
K242612 09/03/2024 Option ELITE Vena Cava Filter System (352506070E 352506100E) Argon Medical Devices, Inc.
K160785 03/22/2016 Worker Guidewire ARGON MEDICAL DEVICES, INC.


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