MMX · Class II · 21 CFR 870.5150

FDA Product Code MMX: Device, Percutaneous Retrieval

Under FDA product code MMX, percutaneous retrieval devices are cleared for the endovascular retrieval of foreign bodies and misplaced objects from the cardiovascular system.

These snare, basket, or grasper devices are delivered through catheters to capture and remove fragmented catheters, guide wires, embolized devices, and other intravascular foreign bodies without open surgery.

MMX devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Argon Medical Devices, Inc., Cook Incorporated and LimFlow, Inc..

32
Total
32
Cleared
107d
Avg days
2002
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 154d recently vs 105d historically

FDA 510(k) Cleared Device, Percutaneous Retrieval Devices (Product Code MMX)

32 devices
1–24 of 32
Cleared Feb 14, 2025
LimFlow V-Ceiver
K242776
LimFlow, Inc.
Cardiovascular · 154d
Cleared Jun 03, 2024
Amplatz Goose Neck Snare Kit
K241259
Medtronic, Inc.
Cardiovascular · 28d
Cleared Sep 07, 2023
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443
Argon Medical Devices, Inc.
Cardiovascular · 24d
Cleared May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254
Cook Incorporated
Cardiovascular · 293d
Cleared Aug 09, 2022
LimFlow V-Ceiver
K222083
LimFlow, Inc.
Cardiovascular · 25d
Cleared May 23, 2022
ONO Retrieval Device
K212988
Onocor Vascular, LLC
Cardiovascular · 245d
Cleared Apr 01, 2022
Aveir Retrieval Catheter
K213494
Abbott Medical
Cardiovascular · 151d
Cleared Jan 05, 2021
Halo Single-Loop Microsnare Kit
K200963
Argon Medical Devices, Inc.
Cardiovascular · 270d
Cleared Jun 03, 2020
Halo™ Single-Loop Snare Kit
K200268
Argon Medical Devices, Inc.
Cardiovascular · 121d
Cleared Jan 17, 2020
Merit ONE Snare System
K193507
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Dec 17, 2019
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K191758
Argon Medical Devices, Inc.
Cardiovascular · 169d
Cleared Nov 06, 2018
Günther Tulip® Vena Cava Filter Retrieval Set
K181757
Cook Incorporated
Cardiovascular · 127d
Cleared Mar 08, 2017
Expro Elite Snare, Sympro Elite Snare
K163307
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Feb 18, 2016
Recovery Cone Removal System
K152136
C.R. Bard, Inc.
Cardiovascular · 202d

About Product Code MMX - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code MMX since 2002, with 32 receiving FDA clearance (average review time: 107 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - MMX Product Code

Recent submissions under MMX have taken an average of 154 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.

MMX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →