FDA 510(k)

血液透析用管路線 AL 系列血液透析用管路線 C18 系列

K 號：K230514 · 2023-06-16

決定日期2023-06-16

產品代碼KOC

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 NIKKISO CO., LTD. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242155DBB-06 PRO 靜脈透析輸送系統（DBB-06 PRO）K242479血液透析用管路線 AL 系列（弓形環）血液透析用管路線 C18 系列 AL-ADC-PU、AL-CDC-PU、C18RDC-PU、C18BDD-PU、C18SFD-PU K242176血液透析用管路線 AL 系列血管線（Archloop）血液透析用管路線 C18 系列血管線（AL-ADC-E(U)，AL-CDC-E(U)，C18RDC-E(U)，C18BDD-E(U)，C18SFD-E(U)K231589血液透析用血管路 AV06C-E K152938DBB-06 靜脈透析輸送系統

相關器械（代碼：KOC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242479血液透析用管路線 AL 系列（弓形環）血液透析用管路線 C18 系列 AL-ADC-PU、AL-CDC-PU、C18RDC-PU、C18BDD-PU、C18SFD-PUNIKKISO CO., LTD.K242176血液透析用管路線 AL 系列血管線（Archloop）血液透析用管路線 C18 系列血管線（AL-ADC-E(U)，AL-CDC-E(U)，C18RDC-E(U)，C18BDD-E(U)，C18SFD-E(U)NIKKISO CO., LTD.K231589血液透析用血管路 AV06C-ENIKKISO CO., LTD.K201207CombiSet SMARTECH 靜脈透析血液管路組，附帶預充設備及整合式危機線技術，CombiSet SMARTECH 靜脈透析血液管路組，附帶預充設備及整合危機線技術，無肝素管路Fresenius Medical Care Renal Therapies Group, LLC K172238CAREline 無氣動力血液透析血管路設備套組Fresenius Medical Care Renal Therapies Group, LLC K160749CRIT-LINE III 血壓室 IIFresenius Medical Care Renal Therapies Group, LLC

官方來源

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