ClearSafe封闭系统
K号: K261041 · 2026-07-10
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决定日期2026-07-10
产品代码FOZ
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
ClearSafe Closed System is the device name listed in this FDA 510(k) record. The listed applicant is MedSource Labs, LLC. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261041. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ClearSafe Closed System?
ClearSafe Closed System is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is MedSource Labs, LLC. The 510(k) number is K261041.
When did ClearSafe Closed System receive FDA 510(k) clearance?
ClearSafe Closed System received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261041.
Who is the listed applicant for ClearSafe Closed System?
The FDA 510(k) record lists MedSource Labs, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClearSafe Closed System?
The FDA product code for ClearSafe Closed System is FOZ.
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MedSource Labs, LLC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：FOZ）
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。
K260432Ruby 介入导管Venocare, Inc.K260165未浸渍中心静脉导管Spectrum VascularK260539MedSource QuickSafe™ 安全静脉留置针；MedSource PurSafe™ 安全静脉留置针MedSource Labs, LLCK253235Introcan Safety® 深部接入 XL 静脉留置针B.Braun Medical, Inc.K252137BD Insyte™ IV 管套Becton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety（14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm；20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm，26G x 14mm）；Polywin Safety Adva（20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm；14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm，26G x 14mm）Poly Medicure Limited
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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