FDA 510(k)

治療導管閉合系統；治療Dextra閉合系統

K 號：K230400 · 2023-11-08

決定日期2023-11-08

產品代碼EZD

諮詢委員會GU

決定Unknown

器材摘要

Cure Catheter Closed System; Cure Dextra Closed System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K230400. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Cure Catheter Closed System; Cure Dextra Closed System?

Cure Catheter Closed System; Cure Dextra Closed System is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Convatec, Inc.. The 510(k) number is K230400.

When did Cure Catheter Closed System; Cure Dextra Closed System receive FDA 510(k) clearance?

Cure Catheter Closed System; Cure Dextra Closed System received FDA 510(k) clearance on 2023-11-08, under 510(k) number K230400.

Who is the listed applicant for Cure Catheter Closed System; Cure Dextra Closed System?

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

What is the FDA product code for Cure Catheter Closed System; Cure Dextra Closed System?

The FDA product code for Cure Catheter Closed System; Cure Dextra Closed System is EZD.

其他以 Convatec, Inc. 為申請人之記錄

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K221593治療超級男性，治療超級女性，治療超級加強版

相關器械（代碼：EZD）

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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