Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
FDA 510(k) K232443 · Argon Medical Devices, Inc.
510(k) numberK232443
Submission
- Device name
- Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- August 14, 2023
- Decision date
- September 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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| K242776 | LimFlow V-CeiverMMX · Special | LimFlow, Inc. | 02/14/2025SE |
| K241259 | Amplatz Goose Neck Snare KitMMX · Special | Medtronic, Inc. | 06/03/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | Cook Incorporated | 05/16/2023SE |
| K222083 | LimFlow V-CeiverMMX · Traditional | LimFlow, Inc. | 08/09/2022SE |
| K212988 | ONO Retrieval DeviceMMX · Traditional | Onocor Vascular, LLC | 05/23/2022SE |
| K213494 | Aveir Retrieval CatheterMMX · Traditional | Abbott Medical | 04/01/2022SE |
| K200963 | Halo Single-Loop Microsnare KitMMX · Traditional | Argon Medical Devices, Inc. | 01/05/2021SE |
| K200268 | Halo Single-Loop Snare KitMMX · Traditional | Argon Medical Devices, Inc. | 06/03/2020SE |
| K193507 | Merit ONE Snare SystemMMX · Special | Merit Medical Systems, Inc. | 01/17/2020SE |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Traditional | Argon Medical Devices, Inc. | 12/17/2019SE |
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|---|---|---|
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | 02/23/2026SE |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special | 02/05/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | 01/20/2026SE |
| K253741 | VStick Vascular Access SetDYB · Special | 12/15/2025SE |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E)DTK · Special | 09/10/2024SE |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C)DYB · Traditional | 08/01/2024SE |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner…QEW · Traditional | 03/28/2024SE |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece…QEW · Traditional | 01/19/2024SE |
| K233432 | 10F Sheath and Dilator SetDYB · Traditional | 12/08/2023SE |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline CathetersLJS · Traditional | 11/30/2023SE |
Questions and answers
When was Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit cleared by the FDA?
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K232443) received a 510(k) decision of Substantially Equivalent on September 7, 2023, 24 days after the submission was received.
What is the product code of K232443?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.