K222340 is an FDA 510(k) clearance for the Chartis Precision Catheter. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K222340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | CBI - Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |