510(k) K162667

Kitazato IUI Catheter by Kitazato Corporation — Product Code MQF

K162667 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Kitazato IUI Catheter". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Kitazato Corporation has at least 10 other 510(k) clearances on record.