LigaPASS™ 系統
K 號：K261374 · 2026-05-27
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器材摘要
LigaPASS™ System is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K261374. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LigaPASS™ System?
LigaPASS™ System is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Medicrea International S.A.S. The 510(k) number is K261374.
When did LigaPASS™ System receive FDA 510(k) clearance?
LigaPASS™ System received FDA 510(k) clearance on 2026-05-27, under 510(k) number K261374.
Who is the listed applicant for LigaPASS™ System?
The FDA 510(k) record lists Medicrea International S.A.S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LigaPASS™ System?
The FDA product code for LigaPASS™ System is OWI.
相關臨床試驗
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相關器械（代碼：OWI）
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。
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