510(k) K243384

Belzer UW® Cold Storage Solution (BTLBUW-001) by Bridge TO Life — Product Code KDN

K243384 is an FDA 510(k) premarket notification submitted by Bridge TO Life for the device "Belzer UW® Cold Storage Solution (BTLBUW-001)". The FDA issued a decision of Substantially Equivalent on March 31, 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.