The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy…
The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter.
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Chartis Catheter | Listed by | Pulmonx, Corp., United States |
| FDA product code | CBI |
| Device type | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5740 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111522 |
| Record published | 2018-10-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -18 to 60 °C |
| Sizes | Outer diameter 2.7 mm; total volume 3 ml; length 72 cm |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.