FDA 510(k)

Evolution 食管支架系统 - 部分覆盖型

K号: K162717 · 2016-12-21

决定日期2016-12-21

产品代码ESW

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决定实质等同

器械摘要

Evolution Esophageal Stent System – Partially Covered is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162717. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Evolution Esophageal Stent System – Partially Covered?

Evolution Esophageal Stent System – Partially Covered is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K162717.

When did Evolution Esophageal Stent System – Partially Covered receive FDA 510(k) clearance?

Evolution Esophageal Stent System – Partially Covered received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162717.

Who is the listed applicant for Evolution Esophageal Stent System – Partially Covered?

FDA 510(k)记录中列出Cook Ireland, Ltd.为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Evolution Esophageal Stent System – Partially Covered?

The FDA product code for Evolution Esophageal Stent System – Partially Covered is ESW.

列明Cook Ireland, 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。

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