FlexSeal 引導鞘，具有親水塗層
K 號：K161659 · 2016-07-15
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器材摘要
FlexSeal Introducer Sheath with Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Libramedical, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161659. 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 FlexSeal Introducer Sheath with Hydrophilic Coating?
FlexSeal Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Libramedical, Inc.. The 510(k) number is K161659.
When did FlexSeal Introducer Sheath with Hydrophilic Coating receive FDA 510(k) clearance?
FlexSeal Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161659.
Who is the listed applicant for FlexSeal Introducer Sheath with Hydrophilic Coating?
The FDA 510(k) record lists Libramedical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FlexSeal Introducer Sheath with Hydrophilic Coating?
The FDA product code for FlexSeal Introducer Sheath with Hydrophilic Coating is DYB.
相關臨床試驗
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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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