510(k) K150611

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

K150611 is an FDA 510(k) premarket notification submitted by Medsource International for the device "MedSource ClearSafe Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on July 15, 2015. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Medsource International has at least 9 other 510(k) clearances on record.

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