# K083883: Chartis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonx, Inc.
- Decided: Jun 25, 2009 after 178 days
- Product code: CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894337 (1989). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021920: 7.0 FR. Endobronchial Blocker, Cook, Inc. (2002) Summary page 1.

## Most influential descendants
- K111522: Chartis Catheter Model CHR-CA-12.0 (2011), 2 descendants of its own
- K222340: Chartis Precision Catheter (2022), 1 descendant of its own
- K253096: Chartis Precision Catheter (2026), 0 descendants of its own

## Indications for use
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.

Source page: https://510kreport.com/device/K083883
Methodology: https://510kreport.com/methodology