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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K253096
Device Name Chartis Precision Catheter
Applicant
Pulmonx Corporation
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Applicant Contact Leah Andre
Correspondent
Pulmonx Corporation
700 Chesapeake Dr.
Redwood Citry,  CA  94063
Correspondent Contact Terry Solomon
Regulation Number868.5740
Classification Product Code
CBI  
Date Received09/23/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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