510(k) K253096

Chartis Precision Catheter by Pulmonx Corporation — Product Code CBI

K253096 is an FDA 510(k) premarket notification submitted by Pulmonx Corporation for the device "Chartis Precision Catheter". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Pulmonx Corporation has at least 3 other 510(k) clearances on record.