FDA 510(k)

血液透析管路AL系列（Archloop），血液透析管路C18系列

K号: K230514 · 2023-06-16

决定日期2023-06-16

产品代码KOC

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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 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 2023-06-16 under 510(k) number K230514. 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?

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K230514.

When did Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series receive FDA 510(k) clearance?

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230514.

Who is the listed applicant for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series?

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?

The FDA product code for Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series is KOC.

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)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-PU 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-E 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。

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.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, LLC K172238CAREline 无菌空气透析血路套装Fresenius Medical Care Renal Therapies Group, LLC K160749CRIT-LINE III 血液腔室 IIFresenius Medical Care Renal Therapies Group, LLC

官方来源

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