# K201489: Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Dec 22, 2020 after 201 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924607 (1993). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171820: Transjugular Liver Access Sets, Cook Incorporated (2018) Summary page 4.

## Most influential descendants
- K213638: Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) (2021), 0 descendants of its own

## Indications for use
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K201489
Methodology: https://510kreport.com/methodology