Cleared Traditional

Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

K202141 · Argon Medical Devices, Inc. · Cardiovascular
Jan 2021
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K202141 is an FDA 510(k) clearance for the Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein 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 January 15, 2021, 168 days after receiving the submission on July 31, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K202141 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date January 15, 2021
Days to Decision 168 days
Submission Type Traditional
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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