Cleared Special

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

K232443 · Argon Medical Devices, Inc. · Cardiovascular
Sep 2023
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K232443 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 September 7, 2023, 24 days after receiving the submission on August 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K232443 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2023
Decision Date September 07, 2023
Days to Decision 24 days
Submission Type Special
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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