FDA 510(k)

TLAB® 靜脈肝細胞穿刺系統 (TF-18C)

K 號：K241145 · 2024-08-01

決定日期2024-08-01

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

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

常見問題

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. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K241145.

When did TLAB® Transvenous Liver Biopsy System (TF-18C) receive FDA 510(k) clearance?

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

Who is the listed applicant for TLAB® Transvenous Liver Biopsy System (TF-18C)?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

其他以 Argon Medical Devices, Inc. 為申請人之記錄

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相關器械（代碼：DYB）

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