Clarus 抽離導管套管
K 號：K200925 · 2021-03-18
廣告
器材摘要
Clarus Peel-Away Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical, LLC. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K200925. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Clarus Peel-Away Introducer Sheath?
Clarus Peel-Away Introducer Sheath is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Clarus Medical, LLC. The 510(k) number is K200925.
When did Clarus Peel-Away Introducer Sheath receive FDA 510(k) clearance?
Clarus Peel-Away Introducer Sheath received FDA 510(k) clearance on 2021-03-18, under 510(k) number K200925.
Who is the listed applicant for Clarus Peel-Away Introducer Sheath?
The FDA 510(k) record lists Clarus Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Clarus Peel-Away Introducer Sheath?
The FDA product code for Clarus Peel-Away Introducer Sheath is GWG.
相關臨床試驗
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。
其他以 Clarus Medical, LLC 為申請人之記錄
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。
相關器械（代碼：GWG）
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。
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。
廣告