克洛諾斯HP - 高壓周邊氣球導管
K 號：K151141 · 2016-01-14
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器材摘要
Cronus HP - High Pressure Peripheral Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151141. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Cronus HP - High Pressure Peripheral Balloon Catheter?
Cronus HP - High Pressure Peripheral Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Nipro Medical Corporation. The 510(k) number is K151141.
When did Cronus HP - High Pressure Peripheral Balloon Catheter receive FDA 510(k) clearance?
Cronus HP - High Pressure Peripheral Balloon Catheter received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151141.
Who is the listed applicant for Cronus HP - High Pressure Peripheral Balloon Catheter?
FDA 510(k) 記錄中將 Nipro 医療公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter?
The FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter is LIT.
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 Nipro Medical Corporation 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：LIT）
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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