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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K230514
Device Name Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
Applicant
NIKKISO CO., LTD.
20-3, Ebisu 4-Chome
Shibuya-Ku,  JP 150-6022
Applicant Contact Satoko Hina
Correspondent
Mic International
4-32-16 Ryogoku
Sumida-Ku,  JP 130-0023
Correspondent Contact Fumiaki Kanai
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/24/2023
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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