510(k) K243870

X°Port Lung Preservation System; X°Port Lung Preservation Solution by Traferox Technologies, Inc. — Product Code KDN

K243870 is an FDA 510(k) premarket notification submitted by Traferox Technologies, Inc. for the device "X°Port Lung Preservation System; X°Port Lung Preservation Solution". The FDA issued a decision of Substantially Equivalent on May 1, 2025. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Traferox Technologies, Inc. has at least 2 other 510(k) clearances on record.