NovoFlow 加强型输尿管支架
K号: K213186 · 2022-02-16
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决定日期2022-02-16
产品代码FAD
咨询委员会GU
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决定Unknown
器械摘要
NovoFlow Reinforced Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2022-02-16 under 510(k) number K213186. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
常见问题
What is the NovoFlow Reinforced Ureteral Stent?
NovoFlow Reinforced Ureteral Stent is a medical device that received FDA 510(k) clearance on 2022-02-16. The listed applicant is Coloplast Corp.. The 510(k) number is K213186.
When did NovoFlow Reinforced Ureteral Stent receive FDA 510(k) clearance?
NovoFlow Reinforced Ureteral Stent received FDA 510(k) clearance on 2022-02-16, under 510(k) number K213186.
Who is the listed applicant for NovoFlow Reinforced Ureteral Stent?
The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NovoFlow Reinforced Ureteral Stent?
The FDA product code for NovoFlow Reinforced Ureteral Stent is FAD.
相关临床试验
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列明Coloplast Corp.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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