Qitexio® 4路旋塞（QIT014）
K号: K242255 · 2025-04-29
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申请人Medex
决定日期2025-04-29
产品代码FMG
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
Qitexio® 4-Way Stopcock (QIT014) is the device name listed in this FDA 510(k) record. The listed applicant is Medex. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K242255. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Qitexio® 4-Way Stopcock (QIT014)?
Qitexio® 4-Way Stopcock (QIT014) is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Medex. The 510(k) number is K242255.
When did Qitexio® 4-Way Stopcock (QIT014) receive FDA 510(k) clearance?
Qitexio® 4-Way Stopcock (QIT014) received FDA 510(k) clearance on 2025-04-29, under 510(k) number K242255.
Who is the listed applicant for Qitexio® 4-Way Stopcock (QIT014)?
The FDA 510(k) record lists Medex as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Qitexio® 4-Way Stopcock (QIT014)?
The FDA product code for Qitexio® 4-Way Stopcock (QIT014) is FMG.
相关临床试验
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。
列明Medex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。
相关器械（代码：FMG）
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。
K223499三通截止阀M/S Romsons InternationalK223175腔内给药套装，带旋塞和歧管Baxter Healthcare CorporationK211204SafePort™ 多路阀（或旋塞）Elcam Medical AcalK210516Clicky 十字Yomura Technologies, Inc.K190539TurnSignal 止血夹无菌，TurnSignal 止血夹非无菌，TurnSignal 配有歧管的止血夹无菌，TurnSignal 配有歧管的止血夹非无菌Monumedical, LLCK190489Elcam 停止阀和歧管Elcam Medical Acal
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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