The following data is part of a premarket notification filed by Pulmonx, Inc. with the FDA for Chartis Catheter.
| Device ID | K083883 |
| 510k Number | K083883 |
| Device Name: | CHARTIS CATHETER |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | PULMONX, INC. 24125 85TH AVE SE Woodinville, WA 98272 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines PULMONX, INC. 24125 85TH AVE SE Woodinville, WA 98272 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-06-25 |
| Summary: | summary |