Cleared Special

Option ELITE Vena Cava Filter System (352506070E 352506100E)

K242612 · Argon Medical Devices, Inc. · Cardiovascular
Sep 2024
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K242612 is an FDA 510(k) clearance for the Option ELITE Vena Cava Filter System (352506070E 352506100E), a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on September 10, 2024, 7 days after receiving the submission on September 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K242612 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2024
Decision Date September 10, 2024
Days to Decision 7 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTK — Filter, Intravascular, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3375

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