# K202141: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Jan 15, 2021 after 168 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- 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
- K213002: SCORPION Portal Vein Access Set (2021), 0 descendants of its own

## Recalls of this device
- Jul 8, 2021 · Class II · Z-2501-2021: As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

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

Source page: https://510kreport.com/device/K202141
Methodology: https://510kreport.com/methodology