510(k) K150611

MedSource ClearSafe Safety IV Catheter by Medsource International — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2015
Date Received
March 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type