FDA 510(k)

Chartis精準導管

K 號：K253096 · 2026-02-13

決定日期2026-02-13

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Pulmonx Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K222340Chartis精準導管 K212494肺影像分析 K180011肺龍 Chartis 平板控制台

相關器械（代碼：CBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

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