BD SmartSite™ 无针连接器
K号: K223088 · 2023-04-07
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申请人Care Fusion
决定日期2023-04-07
产品代码FPA
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
BD SmartSite™ Needle-Free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223088. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD SmartSite™ Needle-Free Connector?
BD SmartSite™ Needle-Free Connector is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Care Fusion. The 510(k) number is K223088.
When did BD SmartSite™ Needle-Free Connector receive FDA 510(k) clearance?
BD SmartSite™ Needle-Free Connector received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223088.
Who is the listed applicant for BD SmartSite™ Needle-Free Connector?
The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD SmartSite™ Needle-Free Connector?
The FDA product code for BD SmartSite™ Needle-Free Connector is FPA.
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Care Fusion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：FPA）
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。
K254123Ecomed 一次性给药套装Ecomed Solutions, LLCK261530iiSure 静脉输液器Deka Research and DevelopmentK252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）Amsino International, Inc.K251375PuraCath Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵输液套装Carefusion (Bd)
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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