FDA 510(k)

Chartis Precision Catheter

K-Number: K253096 · 2026-02-13

Decision Date2026-02-13

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Chartis Precision Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K253096. 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 2026-02-13. The listed applicant is Pulmonx Corporation. The 510(k) number is K253096.

When did Chartis Precision Catheter receive FDA 510(k) clearance?

Chartis Precision Catheter received FDA 510(k) clearance on 2026-02-13, under 510(k) number K253096.

Who is the listed applicant for Chartis Precision Catheter?

The FDA 510(k) record lists Pulmonx Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chartis Precision Catheter?

The FDA product code for Chartis Precision Catheter is CBI.

Other records listing Pulmonx Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P180002Valve, pulmonary K222340Chartis Precision Catheter K212494Lung Image Analysis K180011Pulmonx Chartis Tablet Console

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.