HQS 引導器（型號 2064-HQS）
K 號：K153494 · 2016-08-25
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器材摘要
HQS Introducer (Model 2064-HQS) is the device name listed in this FDA 510(k) record. The listed applicant is Alseal. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K153494. 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 HQS Introducer (Model 2064-HQS)?
HQS Introducer (Model 2064-HQS) is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Alseal. The 510(k) number is K153494.
When did HQS Introducer (Model 2064-HQS) receive FDA 510(k) clearance?
HQS Introducer (Model 2064-HQS) received FDA 510(k) clearance on 2016-08-25, under 510(k) number K153494.
Who is the listed applicant for HQS Introducer (Model 2064-HQS)?
The FDA 510(k) record lists Alseal as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HQS Introducer (Model 2064-HQS)?
The FDA product code for HQS Introducer (Model 2064-HQS) is DYB.
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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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