Cleared Traditional

Halo™ Single-Loop Snare Kit (K200268) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200268 · Argon Medical Devices, Inc. · Cardiovascular device
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Jun 2020
Decision
121d
Days
Class 2
Risk

K200268 is an FDA 510(k) clearance for the Halo™ Single-Loop Snare 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 June 3, 2020 after a review of 121 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K200268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2020
Decision Date June 03, 2020
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K200268.
ONO Retrieval Device
K212988 · Onocor Vascular, LLC · May 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022
Halo Single-Loop Microsnare Kit
K200963 · Argon Medical Devices, Inc. · Jan 2021
Merit ONE Snare System
K193507 · Merit Medical Systems, Inc. · Jan 2020
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K191758 · Argon Medical Devices, Inc. · Dec 2019
Günther Tulip® Vena Cava Filter Retrieval Set
K181757 · Cook Incorporated · Nov 2018