FDA 510(k)

血液采集针（带/不带针座）

K号: K223323 · 2023-03-24

申请人Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

决定日期2023-03-24

产品代码JKA

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Blood Collection Needle (with/without Needle Holder) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223323. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blood Collection Needle (with/without Needle Holder)?

Blood Collection Needle (with/without Needle Holder) is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K223323.

When did Blood Collection Needle (with/without Needle Holder) receive FDA 510(k) clearance?

Blood Collection Needle (with/without Needle Holder) received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223323.

Who is the listed applicant for Blood Collection Needle (with/without Needle Holder)?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Collection Needle (with/without Needle Holder)?

The FDA product code for Blood Collection Needle (with/without Needle Holder) is JKA.

列明Anhui Hongyu Wuzhou Medical Manufacturer Co., 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。

K234024HWJECT自动失效注射器 K230061胰岛素注射器 K230043胰岛素笔针 K222124带/不带针的无菌皮下注射器，皮下针 K222141安全血液采集针（不带针筒夹）K220900带/不带针筒夹的安全血液采集针

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相关器械（代码：JKA）

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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官方来源

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