FDA 510(k)

无菌單次使用高壓血管造影針筒

K 號：K182289 · 2018-10-10

申請人Shenzhen Baoan Medical Supplies Co., Ltd.

決定日期2018-10-10

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 Shenzhen Baoan Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K182289. 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 2018-10-10. The listed applicant is Shenzhen Baoan Medical Supplies Co., Ltd.. The 510(k) number is K182289.

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 2018-10-10, under 510(k) number K182289.

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

The FDA 510(k) record lists Shenzhen Baoan Medical Supplies 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.

其他以 Shenzhen Baoan Medical Supplies 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。

K151960无菌單次使用高壓血管造影針筒

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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