The following data is part of a premarket notification filed by Pulmonx Corporation with the FDA for Chartis Precision Catheter.
| Device ID | K222340 |
| 510k Number | K222340 |
| Device Name: | Chartis Precision Catheter |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | Pulmonx Corporation 700 Chesapeake Road Redwood City, CA 94063 |
| Contact | Aniket Khakhadiya |
| Correspondent | Aniket Khakhadiya Pulmonx Corporation 700 Chesapeake Road Redwood City, CA 94063 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-12-01 |