ConvertX 肾盂输尿管支架系统
K号: K161277 · 2016-11-22
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决定日期2016-11-22
产品代码FAD
咨询委员会GU
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决定实质等同
器械摘要
ConvertX Nephroureteral Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Brightwater Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161277. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ConvertX Nephroureteral Stent System?
ConvertX Nephroureteral Stent System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Brightwater Medical. The 510(k) number is K161277.
When did ConvertX Nephroureteral Stent System receive FDA 510(k) clearance?
ConvertX Nephroureteral Stent System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161277.
Who is the listed applicant for ConvertX Nephroureteral Stent System?
The FDA 510(k) record lists Brightwater Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ConvertX Nephroureteral Stent System?
The FDA product code for ConvertX Nephroureteral Stent System is FAD.
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。
列明Brightwater Medical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。
相关器械（代码：FAD）
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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