FDA 510(k)

一次性間斷導尿管（TPU 尿管）

K 號：K243175 · 2025-06-26

申請人Chengdu Daxan Innovative Medical Tech. Co., Ltd.

決定日期2025-06-26

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

Disposable Intermittent Catheter (TPU Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243175. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Intermittent Catheter (TPU Catheter)?

Disposable Intermittent Catheter (TPU Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K243175.

When did Disposable Intermittent Catheter (TPU Catheter) receive FDA 510(k) clearance?

Disposable Intermittent Catheter (TPU Catheter) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243175.

Who is the listed applicant for Disposable Intermittent Catheter (TPU Catheter)?

The FDA 510(k) record lists Chengdu Daxan Innovative Medical Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Intermittent Catheter (TPU Catheter)?

The FDA product code for Disposable Intermittent Catheter (TPU Catheter) is EZD.

其他以 Chengdu Daxan Innovative Medical Tech. 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。

K212567PVC親水性尿道導尿管

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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