# K241145: TLAB® Transvenous Liver Biopsy System (TF-18C)

- Pathway: 510(k) (Traditional)
- Applicant: Argon Medical Devices, Inc.
- Decided: Aug 1, 2024 after 98 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: 1 generation back to K022634 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022634: CO-Axial Introducer Needle, Promex, Inc. (2002) Summary page 4.

## Indications for use
The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K241145
Methodology: https://510kreport.com/methodology