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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K161779
Device Name MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
Applicant
Medsource International, LLC
401 Norex Dr.
Chaska,  MN  55318
Applicant Contact Laura Riggen
Correspondent
Medsource International, LLC
401 Norex Dr.
Chaska,  MN  55318
Correspondent Contact Laura Riggen
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/29/2016
Decision Date 11/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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