套管導入器
K 號：K150932 · 2016-07-22
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器材摘要
Sheath Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corp.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K150932. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sheath Introducer?
Sheath Introducer is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Bioteque Corp.. The 510(k) number is K150932.
When did Sheath Introducer receive FDA 510(k) clearance?
Sheath Introducer received FDA 510(k) clearance on 2016-07-22, under 510(k) number K150932.
Who is the listed applicant for Sheath Introducer?
The FDA 510(k) record lists Bioteque Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sheath Introducer?
The FDA product code for Sheath Introducer is DRE.
相關臨床試驗
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相關器械（代碼：DRE）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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