Cleared Traditional

Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

K201489 · Argon Medical Devices, Inc. · Cardiovascular
Dec 2020
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K201489 is an FDA 510(k) clearance for the Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga 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 December 22, 2020, 201 days after receiving the submission on June 4, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K201489 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2020
Decision Date December 22, 2020
Days to Decision 201 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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