Cleared Traditional

Chartis Precision Catheter

K222340 · Pulmonx Corporation · Anesthesiology

Dec 2022

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K222340 is an FDA 510(k) clearance for the Chartis Precision Catheter, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Pulmonx Corporation (Redwood City, US). The FDA issued a Cleared decision on December 1, 2022, 120 days after receiving the submission on August 3, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K222340 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2022
Decision Date	December 01, 2022
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740