PRAEVAorta®2
K号: K243859 · 2025-08-29
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器械摘要
PRAEVAorta®2 is the device name listed in this FDA 510(k) record. The listed applicant is Nurea. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K243859. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PRAEVAorta®2?
PRAEVAorta®2 is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Nurea. The 510(k) number is K243859.
When did PRAEVAorta®2 receive FDA 510(k) clearance?
PRAEVAorta®2 received FDA 510(k) clearance on 2025-08-29, under 510(k) number K243859.
Who is the listed applicant for PRAEVAorta®2?
The FDA 510(k) record lists Nurea as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PRAEVAorta®2?
The FDA product code for PRAEVAorta®2 is QIH.
相关临床试验
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相关器械（代码：QIH）
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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