K243870

X°Port Lung Preservation System; X°Port Lung Preservation Solution

510(k) number: K243870
Device name: X°Port Lung Preservation System; X°Port Lung Preservation Solution
Applicant: Traferox Technologies, Inc. CA
Product code: KDN — System, Perfusion, Kidney
Decision date: 2025-05-01
Date received: 2024-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

Also available from FDA: K243870.pdf

Official FDA record: K243870

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.