FDA 510(k)

導入鞘套組

K 號：K242248 · 2024-08-22

申請人Beijing Demax Medical Technology Co.,Ltd

決定日期2024-08-22

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Introducer Sheath Kits is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K242248. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Introducer Sheath Kits?

Introducer Sheath Kits is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K242248.

When did Introducer Sheath Kits receive FDA 510(k) clearance?

Introducer Sheath Kits received FDA 510(k) clearance on 2024-08-22, under 510(k) number K242248.

Who is the listed applicant for Introducer Sheath Kits?

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

What is the FDA product code for Introducer Sheath Kits?

The FDA product code for Introducer Sheath Kits is DYB.

其他以 Beijing Demax Medical Technology 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。

K222184導入鞘套組 K222182桡動脈壓縮止血帶

相關器械（代碼：DYB）

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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