510(k) K131555

MEDSOURCE IV SAFETY CATHETER by Medsource International, LLC — Product Code FOZ

K131555 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MEDSOURCE IV SAFETY CATHETER". The FDA issued a decision of Substantially Equivalent on January 31, 2014. 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, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2014
Date Received
May 29, 2013
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