Radius Snare
FDA 510(k) K021441 · Radius Medical Technologies, Inc.
510(k) numberK021441
Submission
- Device name
- Radius Snare
- Applicant
- Radius Medical Technologies, Inc.
Maynard, MA, US - Received
- May 6, 2002
- Decision date
- June 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX · Special | Argon Medical Devices, Inc. | 09/07/2023SE |
| 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 |
More from Merit Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070502 | Radius SnareDQY · Traditional | 10/04/2007SE |
| K071457 | Modification to Radius SnareMMX · Special | 09/25/2007SE |
| K032899 | Radius Cougar WireDQX · Special | 10/17/2003SE |
| K032129 | Radius 018 Cougar WireDQX · Special | 07/17/2003SE |
| K022201 | Radius Micro SnareMMX · Traditional | 02/03/2003SE |
| K011759 | Radius Next Generation GuidewireOCY · Traditional | 08/23/2001SE |
| K011287 | Radius Cougar WireDQX · Special | 05/25/2001SE |
| K970466 | Radius Ptca GuidewireLIT · Traditional | 05/20/1997SE |
Questions and answers
When was Radius Snare cleared by the FDA?
Radius Snare (K021441) received a 510(k) decision of Substantially Equivalent on June 14, 2002, 39 days after the submission was received.
What is the product code of K021441?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.