FDA 510(k)

K-Shield Advantage Port Access Infusion Set (PAIS)

K号: K190233 · 2019-05-02

决定日期2019-05-02

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

K-Shield Advantage Port Access Infusion Set (PAIS) is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K190233. 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 K-Shield Advantage Port Access Infusion Set (PAIS)?

K-Shield Advantage Port Access Infusion Set (PAIS) is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K190233.

When did K-Shield Advantage Port Access Infusion Set (PAIS) receive FDA 510(k) clearance?

K-Shield Advantage Port Access Infusion Set (PAIS) received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190233.

Who is the listed applicant for K-Shield Advantage Port Access Infusion Set (PAIS)?

The FDA 510(k) record lists Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-Shield Advantage Port Access Infusion Set (PAIS)?

The FDA product code for K-Shield Advantage Port Access Infusion Set (PAIS) is FPA.

列明Kawasumi Laboratories, Inc.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。

K190485Kawasumi多样本适配器带预装夹具（MBCH）K172957Kawasumi Laboratories血液采集套件（BDK）系统

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。

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