Cleared Special

V?Stick? Vascular Access Set

K253741 · Argon Medical Devices, Inc. · Cardiovascular
Dec 2025
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K253741 is an FDA 510(k) clearance for the V?Stick? Vascular Access Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 15, 2025, 21 days after receiving the submission on November 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K253741 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2025
Decision Date December 15, 2025
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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