FDA 510(k)

PathBuilder 門腔針

K 號：K212625 · 2022-03-23

申請人Shanghai Microport EP Medtech Co., Ltd.

決定日期2022-03-23

產品代碼DRC

諮詢委員會履歷

決定相當於

器材摘要

PathBuilder Transseptal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K212625. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PathBuilder Transseptal Needle?

PathBuilder Transseptal Needle is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212625.

When did PathBuilder Transseptal Needle receive FDA 510(k) clearance?

PathBuilder Transseptal Needle received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212625.

Who is the listed applicant for PathBuilder Transseptal Needle?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathBuilder Transseptal Needle?

The FDA product code for PathBuilder Transseptal Needle is DRC.

其他以 Shanghai Microport EP Medtech Co., Ltd. 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。

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相關器械（代碼：DRC）

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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