510(k) K132153

SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER by Nipro Medical Corporation — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2013
Date Received
July 12, 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