Cleared Traditional

Halo Single-Loop Microsnare Kit

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

About This 510(k) Submission

K200963 is an FDA 510(k) clearance for the Halo Single-Loop Microsnare Kit, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on January 5, 2021, 270 days after receiving the submission on April 10, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K200963 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MMX — Device, Percutaneous Retrieval
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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