510(k) K132153

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

K132153 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER". The FDA issued a decision of Substantially Equivalent on December 5, 2013. 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. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.