# K171820: Transjugular Liver Access Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 9, 2018 after 263 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924607 (1993). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152913: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle, Creganna Medical Aslo Business AS Cregganna Tactx Medical (2016) Summary page 4.

## Most influential descendants
- K202141: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (2021), 1 descendant of its own
- K201489: Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (2020), 1 descendant of its own
- K221440: Liverty™ TIPS Access Set (2022), 0 descendants of its own
- 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
- K213002: SCORPION Portal Vein Access Set (2021), 0 descendants of its own

## Recalls of this device
- Nov 26, 2025 · Class II · Z-0994-2026: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly t
- Nov 26, 2025 · Class II · Z-0995-2026: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly t

## Indications for use
The Rosch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K171820
Methodology: https://510kreport.com/methodology