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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, triple lumen, non-implanted
510(k) Number K222170
Device Name Power Acute Triple Lumen Hemodialysis Catheter
Applicant
Health Line International Corporation
260 North Ace Yeager Court, Unit D
Salt Lake City,  UT  84116
Applicant Contact Aaron G Faulkner
Correspondent
Health Line International Corporation
260 North Ace Yeager Court, Unit D
Salt Lake City,  UT  84116
Correspondent Contact Aaron G Faulkner
Regulation Number876.5540
Classification Product Code
NIE  
Date Received07/21/2022
Decision Date 01/13/2023
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
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