Crux Snare Filter Retrieval Set
FDA 510(k) K133681 · Volcano Corporation
510(k) numberK133681
Submission
- Device name
- Crux Snare Filter Retrieval Set
- Applicant
- Volcano Corporation
Billerica, MA, US - Received
- December 2, 2013
- Decision date
- January 30, 2014
- 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
Other 510(k)s with product code MMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | 04/15/2021SE |
| K203719 | IntraSight MobileIYO · Special | 01/19/2021SE |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Special | 09/28/2020SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | 03/26/2020SE |
| K190626 | SyncVision SystemOWB · Traditional | 04/12/2019SE |
| K190078 | IntraSightDSA · Special | 02/11/2019SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | 04/11/2018SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | 10/25/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | 10/05/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | 04/06/2017SE |
Questions and answers
When was Crux Snare Filter Retrieval Set cleared by the FDA?
Crux Snare Filter Retrieval Set (K133681) received a 510(k) decision of Substantially Equivalent on January 30, 2014, 59 days after the submission was received.
What is the product code of K133681?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.