510(k) K173103

Pivet and Soft-Pass Embryo Transfer Catheter Sets by Cook Incorporated — Product Code MQF

K173103 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Pivet and Soft-Pass Embryo Transfer Catheter Sets". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code MQF (Catheter, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6110. Cook Incorporated has at least 10 other 510(k) clearances on record.