FDA 510(k)

ProSeal™带添加剂端口的袋刺（423370ST，423370）

K号: K251340 · 2025-05-29

决定日期2025-05-29

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

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251340. 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 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K251340.

When did ProSeal™ Bag Spike with Additive Port (423370ST, 423370) receive FDA 510(k) clearance?

ProSeal™ Bag Spike with Additive Port (423370ST, 423370) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251340.

Who is the listed applicant for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

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

What is the FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370)?

The FDA product code for ProSeal™ Bag Spike with Additive Port (423370ST, 423370) is ONB.

列明Epic Medical Pte. , 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。

K252987ADRx® 混合设备 K250234SMARTeZ® 弹性输液泵（RS 系列）K251722ProSeal™ 转移注射器 (421120, 421130, 421140)K251814EZ® 静脉注射给药装置 K252094eZSURE™ 空液容器 K243976ZeroClear™袋接入（423100）

查看所有 22 个设备 →

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.K243976ZeroClear™袋接入（423100）Epic Medical Pte. , Ltd.K240517ProSeal™ 带排气孔的通用安瓿瓶适配器Epic Medical Pte. , Ltd.

官方来源

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