安全修復易出系統
K 號：K180753 · 2018-04-20
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器材摘要
SafetyFix EasyOut System is the device name listed in this FDA 510(k) record. The listed applicant is Safetyfix Medical Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180753. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the SafetyFix EasyOut System?
SafetyFix EasyOut System is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Safetyfix Medical Technologies, Inc.. The 510(k) number is K180753.
When did SafetyFix EasyOut System receive FDA 510(k) clearance?
SafetyFix EasyOut System received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180753.
Who is the listed applicant for SafetyFix EasyOut System?
The FDA 510(k) record lists Safetyfix Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafetyFix EasyOut System?
The FDA product code for SafetyFix EasyOut System is HWC. This falls under the Cardiovascular category.
相關臨床試驗
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相關器械（代碼：HWC）
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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