FDA 510(k)

带/不带针筒夹的安全血液采集针

K号: K220900 · 2022-08-10

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

决定日期2022-08-10

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

Safety Blood Collection Needles 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 2022-08-10 under 510(k) number K220900. 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 Safety Blood Collection Needles with/without Needle Holder?

Safety Blood Collection Needles with/without Needle Holder is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K220900.

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

Safety Blood Collection Needles with/without Needle Holder received FDA 510(k) clearance on 2022-08-10, under 510(k) number K220900.

Who is the listed applicant for Safety Blood Collection Needles 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 Safety Blood Collection Needles with/without Needle Holder?

The FDA product code for Safety Blood Collection Needles 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 K223323血液采集针（带/不带针座）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）

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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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