Cleared Traditional

Halo? Single-Loop Snare Kit

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

About This 510(k) Submission

K200268 is an FDA 510(k) clearance for the Halo? Single-Loop Snare 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 June 3, 2020, 121 days after receiving the submission on February 3, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K200268 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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