StrataMR 阀门和分流器
K号: K152700 · 2016-04-07
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决定日期2016-04-07
产品代码JXG
咨询委员会NE
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决定实质等同
器械摘要
StrataMR Valves and Shunts is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K152700. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the StrataMR Valves and Shunts?
StrataMR Valves and Shunts is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K152700.
When did StrataMR Valves and Shunts receive FDA 510(k) clearance?
StrataMR Valves and Shunts received FDA 510(k) clearance on 2016-04-07, under 510(k) number K152700.
Who is the listed applicant for StrataMR Valves and Shunts?
The FDA 510(k) record lists Medtronic Neurosurgery as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for StrataMR Valves and Shunts?
The FDA product code for StrataMR Valves and Shunts is JXG.
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Medtronic Neurosurgery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：JXG）
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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