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FDA 510(k)

MiniCap延长寿命PD转移套装带旋转夹 - 编码5C4482A；MiniCap延长寿命PD转移套装带旋转夹 - 非常短 - 编码5C4483

K号: K231849 · 2024-03-12

申请人Baxter Healthcare
决定日期2024-03-12
产品代码KDJ
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

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare. It received FDA 510(k) clearance on 2024-03-12 under 510(k) number K231849. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483?

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 is a medical device that received FDA 510(k) clearance on 2024-03-12. The listed applicant is Baxter Healthcare. The 510(k) number is K231849.

When did MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 receive FDA 510(k) clearance?

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 received FDA 510(k) clearance on 2024-03-12, under 510(k) number K231849.

Who is the listed applicant for MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483?

The FDA 510(k) record lists Baxter Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483?

The FDA product code for MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 is KDJ.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Baxter Healthcare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。

K192705MiniCap延长寿命PD转移套装

相关器械（代码：KDJ）

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。

K250404stay•safe® 安全锁定导尿管延长管套装，12英寸；stay•safe® Luer-Lock导尿管延长管套装，6英寸；stay•safe® Luer-Lock导尿管延长管套装，12英寸；stay•safe® Luer-Lock导尿管延长管套装，18英寸；stay•safe® 至 Luer-Lock 转换器，4英寸Fresenius Medical Care Renal Therapies Group, LLCK21401615L 循环器引流袋Baxter Healthcare CorporationK192705MiniCap延长寿命PD转移套装Baxter HealthcareK173593安全锁闭式留置导管延长管套装，12英寸，安全锁闭式留置导管延长管套装，6英寸，安全锁闭式留置导管延长管套装，12英寸，安全锁闭式留置导管延长管套装，18英寸，安全留置导管至Luer-Lock适配器，4英寸Fresenius Medical Care Renal Therapies Group, LLCK173651带安全PIN连接器的多管段套装，带安全引流套装Fresenius Medical Care Renal Therapies Group, LLCK173363Cycler引流袋套装Fresenius Medical Care Renal Therapies Group, LLC

官方来源

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