FDA 510(k)

SiteSeal SV

K 號：K210681 · 2021-04-06

決定日期2021-04-06

產品代碼DXC

諮詢委員會履歷

決定相當於

器材摘要

SiteSeal SV is the device name listed in this FDA 510(k) record. The listed applicant is Ensite Vascular. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K210681. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SiteSeal SV?

SiteSeal SV is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Ensite Vascular. The 510(k) number is K210681.

When did SiteSeal SV receive FDA 510(k) clearance?

SiteSeal SV received FDA 510(k) clearance on 2021-04-06, under 510(k) number K210681.

Who is the listed applicant for SiteSeal SV?

The FDA 510(k) record lists Ensite Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SiteSeal SV?

The FDA product code for SiteSeal SV is DXC.

其他以 Ensite Vascular 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。

K190351場地封印 SV

相關器械（代碼：DXC）

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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