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FDA 510(k)

一次性间歇导尿管（TPU 导尿管）

K号: K243175 · 2025-06-26

申请人Chengdu Daxan Innovative Medical Tech. Co., Ltd.
决定日期2025-06-26
产品代码EZD
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Disposable Intermittent Catheter (TPU Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243175. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Intermittent Catheter (TPU Catheter)?

Disposable Intermittent Catheter (TPU Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K243175.

When did Disposable Intermittent Catheter (TPU Catheter) receive FDA 510(k) clearance?

Disposable Intermittent Catheter (TPU Catheter) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243175.

Who is the listed applicant for Disposable Intermittent Catheter (TPU Catheter)?

The FDA 510(k) record lists Chengdu Daxan Innovative Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Intermittent Catheter (TPU Catheter)?

The FDA product code for Disposable Intermittent Catheter (TPU Catheter) is EZD.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Chengdu Daxan Innovative Medical Tech. 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。

K212567PVC 亲水性尿道导管

相关器械（代码：EZD）

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。

K261418Liquick X-treme，Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ 即用型亲水性间歇导尿管女性用（CH06 - CH16）；Cure Aqua™ 即用型亲水性间歇导尿管男性直型（CH06 - CH18）；Cure Aqua™ 即用型亲水性间歇导尿管男性弯型（CH10 - CH18）。ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja软性产品Coloplast A.S.K260394一次性使用亲水性涂层间歇性纳拉通导尿管（NCR）Hangzhou Jimushi Meditech Co., Ltd.K253295Coude袖套IC；Coude Plus袖套ICHollister Incorporated

官方来源

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