14F Duo-Flow® 侧侧双腔导管
K号: K250836 · 2025-08-12
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决定日期2025-08-12
产品代码MPB
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
14F Duo-Flow® Side X Side Double Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K250836. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 14F Duo-Flow® Side X Side Double Lumen Catheter?
14F Duo-Flow® Side X Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Medical Components, Inc.. The 510(k) number is K250836.
When did 14F Duo-Flow® Side X Side Double Lumen Catheter receive FDA 510(k) clearance?
14F Duo-Flow® Side X Side Double Lumen Catheter received FDA 510(k) clearance on 2025-08-12, under 510(k) number K250836.
Who is the listed applicant for 14F Duo-Flow® Side X Side Double Lumen Catheter?
The FDA 510(k) record lists Medical Components, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter?
The FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter is MPB.
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。
相关器械（代码：MPB）
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。
K200426急性双腔血液透析导管Health Line International CorporationK192807Duo-Flow 侧侧双腔导管Medical Components, Inc. (dba MedComp)K192302Mahurkar急性单腔导管，Mahurkar急性双腔导管，Mahurkar急性三腔导管，Mahurkar急性高压三腔导管Covidien, LLCK163458Zenysis 短期透析导管C.R. Bard, Inc.K161504Cook Turbo-Flo HD 急性血液透析导管套装/托盘Cook IncorporatedK153190Zenysis 短期透析导管C.R. Bard, Inc.
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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