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FDA 510(k)

CombiSet 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

K号: K201207 · 2020-09-18

申请人Fresenius Medical Care Renal Therapies Group, LLC
决定日期2020-09-18
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

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201207. 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 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line?

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K201207.

When did CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line receive FDA 510(k) clearance?

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201207.

Who is the listed applicant for CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line?

FDA 510(k)记录中列出Fresenius Medical Care Renal Therapies Group, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line?

The FDA product code for CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line 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Fresenius Medical Care Renal Therapies Group, 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。

K261267Careflux H60；Careflux H70；Careflux V500K252377NxStage System One with NxViewK252459multiFlux 130（F00013123）；multiFlux 160（F00013124）K253462NaturaLyte® 干碳酸氢钠浓缩液（08-4112-2）K253518FX CorAL 40；FX CorAL 50K250634BCM2-身体成分监测仪

查看所有 48 个设备 →

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。

K242479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-PUNIKKISO CO., LTD.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.K172238CAREline 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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