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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialysis Catheter Luer End Cap
510(k) Number K180111
Device Name ClearGuard HD Antimicrobial Barrier Cap
Applicant
Pursuit Vascular, Inc.
6901 E. Fish Lake Rd., Suite 166
Maple Grove,  MN  55369
Applicant Contact Douglas Killion
Correspondent
Pursuit Vascular, Inc.
6901 E. Fish Lake Rd., Suite 166
Maple Grove,  MN  55369
Correspondent Contact Laurie Lynch
Regulation Number876.5540
Classification Product Code
PEH  
Date Received01/16/2018
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02593149
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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