聚二氧杂环己酮手术支架
K号: K181094 · 2018-08-02
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决定日期2018-08-02
产品代码FTL
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Polydioxanone Surgical Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Lntegra Lifesciences. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181094. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Polydioxanone Surgical Scaffold?
Polydioxanone Surgical Scaffold is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Lntegra Lifesciences. The 510(k) number is K181094.
When did Polydioxanone Surgical Scaffold receive FDA 510(k) clearance?
Polydioxanone Surgical Scaffold received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181094.
Who is the listed applicant for Polydioxanone Surgical Scaffold?
The FDA 510(k) record lists Lntegra Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polydioxanone Surgical Scaffold?
The FDA product code for Polydioxanone Surgical Scaffold is FTL.
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。
相关器械（代码：FTL）
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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