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FDA 510(k)

血液透析用管路 AL 系列产品 (Archloop) 血液透析用管路 C18 系列产品 AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU

K号: K242479 · 2025-05-15

申请人NIKKISO CO., LTD.
决定日期2025-05-15
产品代码KOC
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

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU is the device name listed in this FDA 510(k) record. The listed applicant is NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242479. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU?

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K242479.

When did BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU receive FDA 510(k) clearance?

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242479.

Who is the listed applicant for BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU?

The FDA 510(k) record lists NIKKISO CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU?

The FDA product code for BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU is KOC.

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NIKKISO CO., LTD.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。

K242155DBB-06 PRO 血液透析输送系统 (DBB-06 PRO)K242176血液透析用管路 AL 系列产品 (Archloop) 血液透析用管路 C18 系列产品 (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U))K231589血液透析管路AV06C-EK230514血液透析管路AL系列（Archloop），血液透析管路C18系列K152938DBB-06 血液透析输送系统

相关器械（代码：KOC）

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。

K242176血液透析用管路 AL 系列产品 (Archloop) 血液透析用管路 C18 系列产品 (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U))NIKKISO CO., LTD.K231589血液透析管路AV06C-ENIKKISO CO., LTD.K230514血液透析管路AL系列（Archloop），血液透析管路C18系列NIKKISO CO., LTD.K201207CombiSet SMARTECH 血液透析导管套装，附带预充套装和集成 Crit-Line 技术，CombiSet SMARTECH 血液透析导管套装，附带预充套装和集成 Crit-Line 技术，无肝素管Fresenius Medical Care Renal Therapies Group, LLCK172238CAREline 无菌空气透析血路套装Fresenius Medical Care Renal Therapies Group, LLCK160749CRIT-LINE III 血液腔室 IIFresenius Medical Care Renal Therapies Group, LLC

官方来源

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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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