Chartis Precision Catheter— 510(k) K253096
Substantially EquivalentPulmonx Corporation
FDA 510(k) clearance K253096 for Chartis Precision Catheter, Substantially Equivalent on 2026-02-13. Applicant: Pulmonx Corporation. Device class: 2.
Summary
Pulmonx's Chartis Precision Catheter is filed under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)). The record doesn't describe the catheter beyond its name and that code name.
Class II, 21 CFR 868.5740. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Pulmonx filed from Redwood City, California. The substantially equivalent decision came 143 calendar days after receipt (September 23, 2025 to February 13, 2026).
Clearance details
- Applicant
- Pulmonx Corporation
- Product code
- Product code CBI
- Device class
- Class 2
- Regulation
- 21 CFR 868.5740
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code CBI
view allMore clearances from Pulmonx Corporation
view allAdverse events under product code CBI
product code CBI- Death
- 4
- Malfunction
- 594
- Total
- 598
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.