# K213002: SCORPION Portal Vein Access Set

- Pathway: 510(k) (Special)
- Applicant: Argon Medical Devices
- Decided: Oct 14, 2021 after 24 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)
- K202141: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set, Argon Medical Devices, Inc. (2021) Summary page 4.

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

Source page: https://510kreport.com/device/K213002
Methodology: https://510kreport.com/methodology