Cleared Traditional

K191758 - Single-Loop Snare Retrieval Kit

K191758 is an FDA 510(k) clearance for Single-Loop Snare Retrieval Kit, manufactured by Argon Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K191758 · Argon Medical Devices, Inc. · Cardiovascular device
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Dec 2019
Decision
169d
Days
Class 2
Risk

K191758 is an FDA 510(k) clearance for the Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 17, 2019 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Argon Medical Devices, Inc. devices

FDA 510(k) Submission Details - K191758

510(k) Number K191758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date December 17, 2019
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MMX Device, Percutaneous Retrieval

All 21
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K191758.
Halo Single-Loop Microsnare Kit
K200963 · Argon Medical Devices, Inc. · Jan 2021
Halo™ Single-Loop Snare Kit
K200268 · Argon Medical Devices, Inc. · Jun 2020
Merit ONE Snare System
K193507 · Merit Medical Systems, Inc. · Jan 2020
Günther Tulip® Vena Cava Filter Retrieval Set
K181757 · Cook Incorporated · Nov 2018
Expro Elite Snare, Sympro Elite Snare
K163307 · Vascular Solutions, Inc. · Mar 2017
Indy OTW Vascular Retriever
K160593 · Cook Incorporated · Sep 2016