510(k) K243618

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) by Bridge TO Life — Product Code KDN

K243618 is an FDA 510(k) premarket notification submitted by Bridge TO Life for the device "EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)". The FDA issued a decision of Substantially Equivalent on June 17, 2025. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Bridge TO Life has at least 6 other 510(k) clearances on record.