510(k) K241145

TLAB® Transvenous Liver Biopsy System (TF-18C) by Argon Medical Devices, Inc. — Product Code DYB

K241145 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "TLAB® Transvenous Liver Biopsy System (TF-18C)". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.