Cleared Traditional

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

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

About This 510(k) Submission

K191758 is an FDA 510(k) clearance for the Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval 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 December 17, 2019, 169 days after receiving the submission on July 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K191758 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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