FDA 510(k)

PVC親水性尿道導尿管

K 號：K212567 · 2022-12-07

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

決定日期2022-12-07

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

PVC Hydrophilic Urethral 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 2022-12-07 under 510(k) number K212567. 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 PVC Hydrophilic Urethral Catheter?

PVC Hydrophilic Urethral Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Chengdu Daxan Innovative Medical Tech. Co., Ltd.. The 510(k) number is K212567.

When did PVC Hydrophilic Urethral Catheter receive FDA 510(k) clearance?

PVC Hydrophilic Urethral Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K212567.

Who is the listed applicant for PVC Hydrophilic Urethral 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 PVC Hydrophilic Urethral Catheter?

The FDA product code for PVC Hydrophilic Urethral Catheter is EZD.

其他以 Chengdu Daxan Innovative Medical Tech. Co., Ltd. 為申請人之記錄

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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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