SiteSeal 髋部壓縮設備
K 號：K192413 · 2020-03-31
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器材摘要
SiteSeal Femoral Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Ensite Vacular, LLC. It received FDA 510(k) clearance on 2020-03-31 under 510(k) number K192413. 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 Femoral Compression Device?
SiteSeal Femoral Compression Device is a medical device that received FDA 510(k) clearance on 2020-03-31. The listed applicant is Ensite Vacular, LLC. The 510(k) number is K192413.
When did SiteSeal Femoral Compression Device receive FDA 510(k) clearance?
SiteSeal Femoral Compression Device received FDA 510(k) clearance on 2020-03-31, under 510(k) number K192413.
Who is the listed applicant for SiteSeal Femoral Compression Device?
The FDA 510(k) record lists Ensite Vacular, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SiteSeal Femoral Compression Device?
The FDA product code for SiteSeal Femoral Compression Device is DXC.
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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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