MMX · Device, Percutaneous Retrieval
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | MMX |
|---|---|
| Device Name | Device, Percutaneous Retrieval |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242776 | LimFlow V-Ceiver | LimFlow, Inc. | Feb 14, 2025 | SESE |
| K241259 | Amplatz Goose Neck Snare Kit | Medtronic, Inc. | Jun 3, 2024 | SESE |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | Sep 7, 2023 | SESE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | Cook Incorporated | May 16, 2023 | SESE |
| K222083 | LimFlow V-Ceiver | LimFlow, Inc. | Aug 9, 2022 | SESE |
| K212988 | ONO Retrieval Device | Onocor Vascular, LLC | May 23, 2022 | SESE |
| K213494 | Aveir Retrieval Catheter | ABBOTT MEDICAL | Apr 1, 2022 | SESE |
| K200963 | Halo Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | Jan 5, 2021 | SESE |
| K200268 | Halo Single-Loop Snare Kit | Argon Medical Devices, Inc. | Jun 3, 2020 | SESE |
| K193507 | Merit ONE Snare System | Merit Medical Systems, Inc. | Jan 17, 2020 | SESE |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc. | Dec 17, 2019 | SESE |
| K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated | Nov 6, 2018 | SESE |
| K170987 | Captus Vascular Retrieval System | Avantec Vascular Corporation | Aug 28, 2017 | SESE |
| K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | Mar 8, 2017 | SESE |
| K160593 | Indy OTW Vascular Retriever | Cook Incorporated | Sep 2, 2016 | SESE |
| K152136 | Recovery Cone Removal System | C.R. Bard, Inc. | Feb 18, 2016 | SESE |
| K152560 | Bard Snare Retrieval Kit | Neometrics, Inc. | Oct 23, 2015 | SESE |
| K151497 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | Jul 1, 2015 | SESE |
| K142265 | ONE Snare Endovascular Microsnare System | Merit Medical Systems, Inc. | Nov 13, 2014 | SESE |
| K133681 | CRUX SNARE FILTER RETRIEVAL SET | Volcano Corporation | Jan 30, 2014 | SESE |
Top Applicants
- Merit Medical Systems, Inc. — 5 clearances
- Argon Medical Devices, Inc. — 4 clearances
- Cook Incorporated — 3 clearances
- Radius Medical Technologies, Inc. — 3 clearances
- Idev Technologies, Inc. — 2 clearances
