BD Texium™ 闭式男性鲁尔接头
K号: K223076 · 2023-03-24
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申请人Care Fusion
决定日期2023-03-24
产品代码ONB
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 Texium™ Closed Male Luer is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223076. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD Texium™ Closed Male Luer?
BD Texium™ Closed Male Luer is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Care Fusion. The 510(k) number is K223076.
When did BD Texium™ Closed Male Luer receive FDA 510(k) clearance?
BD Texium™ Closed Male Luer received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223076.
Who is the listed applicant for BD Texium™ Closed Male Luer?
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 Texium™ Closed Male Luer?
The FDA product code for BD Texium™ Closed Male Luer is ONB.
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：ONB）
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。
K251722ProSeal™ 转移注射器 (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28天 20毫米安瓿适配器和13毫米转换器Simplivia Healthcare , Ltd.K250059BD PhaSeal® Optima 连接套件（C83-O）；BD PhaSeal® Optima 喷嘴套件（C180-O）Becton, Dickinson and CompanyK251411Chemfort 女性卢瑞锁适配器Simplivia Healthcare , Ltd.K251340ProSeal™带添加剂端口的袋刺（423370ST，423370）Epic Medical Pte. , Ltd.K243976ZeroClear™袋接入（423100）Epic Medical Pte. , Ltd.
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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