Chartis Precision Catheter— 510(k) K222340

Substantially Equivalent

Pulmonx Corporation

FDA 510(k) clearance K222340 for Chartis Precision Catheter, Substantially Equivalent on 2022-12-01. Applicant: Pulmonx Corporation.

Clearance details

Applicant: Pulmonx Corporation
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2022-08-03
Decision date: 2022-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.