FDA 510(k) Applications Submitted by Ana Jimenez-Hughes
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| K213638 |
11/18/2021 |
Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) |
Argon Medical Devices |
| 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. |
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