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FDA 510(k)

无菌單次使用高壓血管造影針筒

K 號：K201395 · 2020-10-28

申請人Youwo (Guangzhou) Medical Device Co., Ltd.
決定日期2020-10-28
產品代碼DXT
諮詢委員會履歷
決定相當於

器材摘要

Sterile High-pressure Angiographic Syringes for single-use is the device name listed in this FDA 510(k) record. The listed applicant is Youwo (Guangzhou) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K201395. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile High-pressure Angiographic Syringes for single-use?

Sterile High-pressure Angiographic Syringes for single-use is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Youwo (Guangzhou) Medical Device Co., Ltd.. The 510(k) number is K201395.

When did Sterile High-pressure Angiographic Syringes for single-use receive FDA 510(k) clearance?

Sterile High-pressure Angiographic Syringes for single-use received FDA 510(k) clearance on 2020-10-28, under 510(k) number K201395.

Who is the listed applicant for Sterile High-pressure Angiographic Syringes for single-use?

The FDA 510(k) record lists Youwo (Guangzhou) Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile High-pressure Angiographic Syringes for single-use?

The FDA product code for Sterile High-pressure Angiographic Syringes for single-use is DXT.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：DXT）

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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