FDA 510(k)

Lyka® PORT 无针接入装置 (4170Y)

K号: K241058 · 2024-12-18

决定日期2024-12-18

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

Lyka® PORT Needle Free Access Device (4170Y) is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K241058. 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 Lyka® PORT Needle Free Access Device (4170Y)?

Lyka® PORT Needle Free Access Device (4170Y) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Quest Medical, Inc.. The 510(k) number is K241058.

When did Lyka® PORT Needle Free Access Device (4170Y) receive FDA 510(k) clearance?

Lyka® PORT Needle Free Access Device (4170Y) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K241058.

Who is the listed applicant for Lyka® PORT Needle Free Access Device (4170Y)?

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

What is the FDA product code for Lyka® PORT Needle Free Access Device (4170Y)?

The FDA product code for Lyka® PORT Needle Free Access Device (4170Y) is FPA.

列明Quest Medical, 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。

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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。

K254123Ecomed 一次性给药套装Ecomed Solutions, LLC K261530iiSure 静脉输液器Deka Research and Development K252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）Amsino International, Inc.K251375PuraCath Firefly 无针连接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定装置 [6426733]; nSet+ 稳定装置带 nSyte 无针连接器 (NFC) [6426731]; nSyte 无针连接器 (NFC) [6426727]Np Medical K250325BD Alaris 泵输液套装Carefusion (Bd)

官方来源

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