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FDA 510(k)

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

K-Number: K241145 · 2024-08-01

ApplicantArgon Medical Devices, Inc.
Decision Date2024-08-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TLAB® Transvenous Liver Biopsy System (TF-18C) is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-08-01 under approval number K241145. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TLAB® Transvenous Liver Biopsy System (TF-18C)?

TLAB® Transvenous Liver Biopsy System (TF-18C) is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K241145.

When was TLAB® Transvenous Liver Biopsy System (TF-18C) approved by the FDA?

TLAB® Transvenous Liver Biopsy System (TF-18C) received FDA 510(k) clearance on 2024-08-01, under approval number K241145.

What company makes TLAB® Transvenous Liver Biopsy System (TF-18C)?

TLAB® Transvenous Liver Biopsy System (TF-18C) is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for TLAB® Transvenous Liver Biopsy System (TF-18C)?

The FDA product code for TLAB® Transvenous Liver Biopsy System (TF-18C) is DYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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