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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 K131060
Device Name CLEARGUARD HD END CAP
Applicant
Pursuit Vascular, Inc.
6901 E. Fish Lake Rd., Suite 166
Maple Grove,  MN  55369
Applicant Contact LAURIE E LYNCH, PH.D.
Correspondent
Pursuit Vascular, Inc.
6901 E. Fish Lake Rd., Suite 166
Maple Grove,  MN  55369
Correspondent Contact LAURIE E LYNCH, PH.D.
Regulation Number876.5540
Classification Product Code
PEH  
Date Received04/16/2013
Decision Date 12/16/2013
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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