PIVO
K号: K190604 · 2019-05-13
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决定日期2019-05-13
产品代码JKA
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
PIVO is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K190604. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PIVO?
PIVO is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is Velano Vascular. The 510(k) number is K190604.
When did PIVO receive FDA 510(k) clearance?
PIVO received FDA 510(k) clearance on 2019-05-13, under 510(k) number K190604.
Who is the listed applicant for PIVO?
The FDA 510(k) record lists Velano Vascular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PIVO?
The FDA product code for PIVO is JKA.
相关 PubMed 文献
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Velano Vascular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：JKA）
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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