終端內膜壓力感知鞘套組
K 號：K160272 · 2016-03-04
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器材摘要
Endophys Pressure Sensing Sheath Kit is the device name listed in this FDA 510(k) record. The listed applicant is Endophys, Inc.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K160272. 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 Endophys Pressure Sensing Sheath Kit?
Endophys Pressure Sensing Sheath Kit is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Endophys, Inc.. The 510(k) number is K160272.
When did Endophys Pressure Sensing Sheath Kit receive FDA 510(k) clearance?
Endophys Pressure Sensing Sheath Kit received FDA 510(k) clearance on 2016-03-04, under 510(k) number K160272.
Who is the listed applicant for Endophys Pressure Sensing Sheath Kit?
The FDA 510(k) record lists Endophys, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endophys Pressure Sensing Sheath Kit?
The FDA product code for Endophys Pressure Sensing Sheath Kit 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
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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