FDA 510(k)

TLAB®经静脉肝活检系统（TF-18C）

K号: K241145 · 2024-08-01

决定日期2024-08-01

产品代码DYB

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Argon Medical Devices, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252795ZeniCore™ 自动活检仪器（863212100 / ZeniCore 自动活检设备 12ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863212130 / ZeniCore 自动活检设备 12ga x 13cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214100 / ZeniCore 自动活检设备 14ga x 10cm 配同轴导引器套件）；ZeniCore™ 自动活检仪器（863214130 / ZeniCore 自动活检设备 14ga x 13cm 配同轴 K260028CLEANER® 真空血栓切除术系统，CLEANER® 真空吸引导管手柄，CLEANER® 真空吸引罐 K251318VariFuse 可调式输液导管 K253741V•Stick™ 血管通路套装 K242612Option ELITE 下腔静脉滤过系统 (352506070E 352506100E)K233909Cleaner™ Plus 18F 血栓切除术系统 - Cleaner™ Plus 18F 吸引导管，Cleaner™ Plus 18F 手柄带浸软线，Cleaner™ Plus 18F 吸引罐

查看所有 18 个设备 →

相关器械（代码：DYB）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253526NAMIC 扩张器和套管Medline Industries, LP K261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line 可撕开引导器Health Line International Corporation K261492FieldFlex 可弯曲鞘CenterPoint Systems, LLC K260606Echo 大口径引导鞘Echo Medical, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。