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FDA 510(k)

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K 號：K212288 · 2022-06-02

申請人Kai Medtech, LLC
決定日期2022-06-02
產品代碼QJP
諮詢委員會履歷
決定相當於

器材摘要

Minjie Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Kai Medtech, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K212288. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Minjie Catheter System?

Minjie Catheter System is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Kai Medtech, LLC. The 510(k) number is K212288.

When did Minjie Catheter System receive FDA 510(k) clearance?

Minjie Catheter System received FDA 510(k) clearance on 2022-06-02, under 510(k) number K212288.

Who is the listed applicant for Minjie Catheter System?

The FDA 510(k) record lists Kai Medtech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minjie Catheter System?

The FDA product code for Minjie Catheter System is QJP.

相關臨床試驗

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相關器械（代碼：QJP）

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。

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官方來源

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