FDA 510(k)

單次使用无菌高壓血管造影針筒及附件

K 號：K241109 · 2024-08-22

申請人Shenzhen Boon Medical Supply Co., Ltd.

決定日期2024-08-22

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

Single-use Sterile High-pressure Angiographic Syringes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241109. 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 Single-use Sterile High-pressure Angiographic Syringes and Accessories?

Single-use Sterile High-pressure Angiographic Syringes and Accessories is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Shenzhen Boon Medical Supply Co., Ltd.. The 510(k) number is K241109.

When did Single-use Sterile High-pressure Angiographic Syringes and Accessories receive FDA 510(k) clearance?

Single-use Sterile High-pressure Angiographic Syringes and Accessories received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241109.

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

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

What is the FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories?

The FDA product code for Single-use Sterile High-pressure Angiographic Syringes and Accessories is DXT.

其他以 Shenzhen Boon Medical Supply 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。

K211564无菌單次使用高壓血管造影針筒 K192657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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