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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K241581
Device Name Hemodialysis Catheter
Applicant
Haolang Medical USA Corporation
1100 Bellevue Way NE 8a-533
Bellevue,  WA  98004
Applicant Contact Lisa Xu
Correspondent
Haolang Medical USA Corporation
1100 Bellevue Way NE 8a-533
Bellevue,  WA  98004
Correspondent Contact Lisa Xu
Regulation Number876.5540
Classification Product Code
MSD  
Date Received06/03/2024
Decision Date 05/16/2025
Decision Substantially Equivalent - Kit (SESK)
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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