FDA 510(k)

一次性经皮肾造口扩张套件

K号: K250448 · 2025-07-03

申请人Shenzhen Trious Medical Technology Co., Ltd.

决定日期2025-07-03

产品代码LJE

决定实质等同

器械摘要

Disposable Percutaneous Nephrostomy Dilatation Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250448. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Percutaneous Nephrostomy Dilatation Kit?

Disposable Percutaneous Nephrostomy Dilatation Kit is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K250448.

When did Disposable Percutaneous Nephrostomy Dilatation Kit receive FDA 510(k) clearance?

Disposable Percutaneous Nephrostomy Dilatation Kit received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250448.

Who is the listed applicant for Disposable Percutaneous Nephrostomy Dilatation Kit?

The FDA 510(k) record lists Shenzhen Trious Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit?

The FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit is LJE.

列明Shenzhen Trious Medical Technology Co., Ltd.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。

K243830一次性输尿管支架 K243710一次性输尿管通路鞘

相关器械（代码：LJE）

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。

K222705引入针Youcare Technology Co.,Ltd. (Wuhan)K211911Kolibri 经皮肾造瘘导管，Kolibri 经皮肾造瘘套装，Kolibri 直接穿刺套装Coloplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope 环形肾造口套装，Ultrathane 肾造口套装带 Mac-Loc，Ultrathane 腹股沟套装带 Mac-LocCook Incorporated K190903Lawson 逆行肾造口钢丝穿刺套装Cook Incorporated K183051Kaye肾造瘘冲洗球囊导管和支架套装Cook Incorporated

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