Cleared Traditional

K201489 - Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K201489 is an FDA 510(k) clearance for the Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 22, 2020 after a review of 201 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Argon Medical Devices, Inc. devices

Submission Details

510(k) Number K201489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 700
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