CardioCel 3D
K号: K170951 · 2017-04-28
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决定日期2017-04-28
产品代码PSQ
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]
---
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
CardioCel 3D is the device name listed in this FDA 510(k) record. The listed applicant is Admedus Regen Pty, Ltd.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170951. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CardioCel 3D?
CardioCel 3D is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Admedus Regen Pty, Ltd.. The 510(k) number is K170951.
When did CardioCel 3D receive FDA 510(k) clearance?
CardioCel 3D received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170951.
Who is the listed applicant for CardioCel 3D?
The FDA 510(k) record lists Admedus Regen Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardioCel 3D?
The FDA product code for CardioCel 3D is PSQ.
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Admedus Regen Pty, 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：PSQ）
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。
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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