Zilver 518TM 胆道支架；Zilver 635TM 胆道支架
K号: K163169 · 2017-02-07
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决定日期2017-02-07
产品代码FGE
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Unknown
器械摘要
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent 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 2017-02-07 under 510(k) number K163169. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
常见问题
What is the Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163169.
When did Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent receive FDA 510(k) clearance?
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent received FDA 510(k) clearance on 2017-02-07, under 510(k) number K163169.
Who is the listed applicant for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
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 Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?
The FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is FGE.
相关临床试验
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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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相关器械（代码：FGE）
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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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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