Certa 管針
K 號：K171193 · 2017-12-18
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器材摘要
Certa Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. It received FDA 510(k) clearance on 2017-12-18 under 510(k) number K171193. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Certa Catheter?
Certa Catheter is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. The 510(k) number is K171193.
When did Certa Catheter receive FDA 510(k) clearance?
Certa Catheter received FDA 510(k) clearance on 2017-12-18, under 510(k) number K171193.
Who is the listed applicant for Certa Catheter?
The FDA 510(k) record lists Ferrosan Medical Devices Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Certa Catheter?
The FDA product code for Certa Catheter is BSO.
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。
相關器械（代碼：BSO）
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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