# 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)

- Pathway: 510(k) (Special)
- Applicant: Argon Medical Devices
- Decided: Dec 10, 2021 after 22 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: 9 generations back to K924607 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201489: Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set, Argon Medical Devices, Inc. (2020) Summary page 4.

## 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/K213638
Methodology: https://510kreport.com/methodology