Dib UltraNav 過隔膜心導管系統
K 號：K213492 · 2022-03-24
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器材摘要
Dib UltraNav Transseptal Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Dib Ultranav Medical, LLC. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K213492. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dib UltraNav Transseptal Catheter System?
Dib UltraNav Transseptal Catheter System is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Dib Ultranav Medical, LLC. The 510(k) number is K213492.
When did Dib UltraNav Transseptal Catheter System receive FDA 510(k) clearance?
Dib UltraNav Transseptal Catheter System received FDA 510(k) clearance on 2022-03-24, under 510(k) number K213492.
Who is the listed applicant for Dib UltraNav Transseptal Catheter System?
The FDA 510(k) record lists Dib Ultranav Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dib UltraNav Transseptal Catheter System?
The FDA product code for Dib UltraNav Transseptal Catheter System is DYB.
相關臨床試驗
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相關器械（代碼：DYB）
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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