FDA 510(k)

Diana 化疗Clave 转移套装

K号: K190157 · 2019-10-23

决定日期2019-10-23

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

Diana ChemoClave Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical. It received FDA 510(k) clearance on 2019-10-23 under 510(k) number K190157. 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 Diana ChemoClave Transfer Set?

Diana ChemoClave Transfer Set is a medical device that received FDA 510(k) clearance on 2019-10-23. The listed applicant is Icu Medical. The 510(k) number is K190157.

When did Diana ChemoClave Transfer Set receive FDA 510(k) clearance?

Diana ChemoClave Transfer Set received FDA 510(k) clearance on 2019-10-23, under 510(k) number K190157.

Who is the listed applicant for Diana ChemoClave Transfer Set?

The FDA 510(k) record lists Icu Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diana ChemoClave Transfer Set?

The FDA product code for Diana ChemoClave Transfer Set is ONB.

列明Icu Medical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。

K262532NORMOFLO™ 灌洗液加温套装及配件（IR-601，IR-501，IR-61，PL-61）K232048Cogent™ 血流动力学监测系统; Cogent™ HMS K192154Rio 瓶到袋药物复配装置 K190918SwabTip Male Disinfectant Cap K171346Sapphire 套件

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 Company K251411Chemfort 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.

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