FDA 510(k)SeQure® NF和SeQure®微导管
K号: K173430 · 2018-01-26
决定日期2018-01-26
产品代码DQO
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
SeQure® NF and SeQure® Microcatheters is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Medical Therapeutics, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K173430. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SeQure® NF and SeQure® Microcatheters?
SeQure® NF and SeQure® Microcatheters is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Accurate Medical Therapeutics, Ltd.. The 510(k) number is K173430.
When did SeQure® NF and SeQure® Microcatheters receive FDA 510(k) clearance?
SeQure® NF and SeQure® Microcatheters received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173430.
Who is the listed applicant for SeQure® NF and SeQure® Microcatheters?
The FDA 510(k) record lists Accurate Medical Therapeutics, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SeQure® NF and SeQure® Microcatheters?
The FDA product code for SeQure® NF and SeQure® Microcatheters is DQO.
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Accurate Medical Therapeutics, 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。
相关器械（代码：DQO）
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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