牛心包組織補片
K 號：K182493 · 2019-06-18
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器材摘要
Bovine Pericardial Tissue Patch is the device name listed in this FDA 510(k) record. The listed applicant is Tisgenx. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K182493. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bovine Pericardial Tissue Patch?
Bovine Pericardial Tissue Patch is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Tisgenx. The 510(k) number is K182493.
When did Bovine Pericardial Tissue Patch receive FDA 510(k) clearance?
Bovine Pericardial Tissue Patch received FDA 510(k) clearance on 2019-06-18, under 510(k) number K182493.
Who is the listed applicant for Bovine Pericardial Tissue Patch?
The FDA 510(k) record lists Tisgenx as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bovine Pericardial Tissue Patch?
The FDA product code for Bovine Pericardial Tissue Patch is FTM.
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：FTM）
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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