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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, Non-Implanted
510(k) Number K200426
Device Name Acute Dual Lumen Hemodialysis Catheter
Applicant
Health Line International Corporation
5675 W 300 S
Salt Lake City,  UT  84104
Applicant Contact Aaron G. Faulkner
Correspondent
Health Line International Corporation
5675 W 300 S
Salt Lake City,  UT  84104
Correspondent Contact Aaron G. Faulkner
Regulation Number876.5540
Classification Product Code
MPB  
Date Received02/21/2020
Decision Date 12/24/2020
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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