510(k) K111522

CHARTIS CATHETER MODEL CHR-CA-12.0 by Pulmonx, Inc. — Product Code CBI

K111522 is an FDA 510(k) premarket notification submitted by Pulmonx, Inc. for the device "CHARTIS CATHETER MODEL CHR-CA-12.0". The FDA issued a decision of Substantially Equivalent on September 29, 2011. 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, Inc. has at least 4 other 510(k) clearances on record.