510(k) K192540

Kitazato ET Catheters by Kitazato Corporation — Product Code MQF

K192540 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Kitazato ET Catheters". The FDA issued a decision of Substantially Equivalent on May 1, 2020. 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.