Cleared Traditional

K200963 - Halo Single-Loop Microsnare Kit

K200963 is an FDA 510(k) clearance for Halo Single-Loop Microsnare 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 270-day FDA review.

K200963 · Argon Medical Devices, Inc. · Cardiovascular device
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Jan 2021
Decision
270d
Days
Class 2
Risk

K200963 is an FDA 510(k) clearance for the Halo Single-Loop Microsnare 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 January 5, 2021 after a review of 270 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 - K200963

510(k) Number K200963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2020
Decision Date January 05, 2021
Days to Decision 270 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
145d slower than avg
Panel avg: 125d · This submission: 270d
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 25
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K200963.
LimFlow V-Ceiver
K222083 · LimFlow, Inc. · Aug 2022
ONO Retrieval Device
K212988 · Onocor Vascular, LLC · May 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022
Halo™ Single-Loop Snare Kit
K200268 · Argon Medical Devices, Inc. · Jun 2020
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