FDA 510(k)

Microcatheter and guide-wire system

K号: K171665 · 2018-01-11

申请人Suzhou Hengrui Disheng Medical Co., Ltd.

决定日期2018-01-11

产品代码KRA

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

Microcatheter and guide-wire system is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K171665. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Microcatheter and guide-wire system?

Microcatheter and guide-wire system is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K171665.

When did Microcatheter and guide-wire system receive FDA 510(k) clearance?

Microcatheter and guide-wire system received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171665.

Who is the listed applicant for Microcatheter and guide-wire system?

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

What is the FDA product code for Microcatheter and guide-wire system?

The FDA product code for Microcatheter and guide-wire system is KRA.

列明Suzhou Hengrui Disheng Medical 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。

K193653亲水性涂层导丝 K193647Superpipe 血管造影导管

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