FDA 510(k)

一次性导尿管（PVC导尿管，硅胶导尿管，乳胶导尿管）

K号: K170233 · 2017-10-13

决定日期2017-10-13

产品代码EZD

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决定实质等同

器械摘要

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K170233. 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 Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Zhanjiang Star Enterprise Co., Ltd.. The 510(k) number is K170233.

When did Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) receive FDA 510(k) clearance?

Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) received FDA 510(k) clearance on 2017-10-13, under 510(k) number K170233.

Who is the listed applicant for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

The FDA 510(k) record lists Zhanjiang Star Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)?

The FDA product code for Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) is EZD.

列明Zhanjiang Star Enterprise 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。

K170234气管插管；加固气管插管

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 Medical K260737Cure 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）。Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja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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