Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Chartis Precision Catheter

K-Number: K222340 · 2022-12-01

Decision Date2022-12-01
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Chartis Precision Catheter is a medical device manufactured by Pulmonx Corporation. It received FDA 510(k) clearance on 2022-12-01 under approval number K222340. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chartis Precision Catheter?

Chartis Precision Catheter is a medical device that received FDA 510(k) clearance on 2022-12-01. It is manufactured by Pulmonx Corporation. The 510(k) number is K222340.

When was Chartis Precision Catheter approved by the FDA?

Chartis Precision Catheter received FDA 510(k) clearance on 2022-12-01, under approval number K222340.

What company makes Chartis Precision Catheter?

Chartis Precision Catheter is manufactured by Pulmonx Corporation.

What is the FDA product code for Chartis Precision Catheter?

The FDA product code for Chartis Precision Catheter is CBI.

Related Clinical Trials

Other Devices by Pulmonx Corporation

Related Devices (Code: CBI)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.