佩拉塔石擴張導管
K 號：K190492 · 2019-07-18
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器材摘要
Peralta Stone Removal Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Calcula Technologies, Inc.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K190492. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Peralta Stone Removal Catheter?
Peralta Stone Removal Catheter is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Calcula Technologies, Inc.. The 510(k) number is K190492.
When did Peralta Stone Removal Catheter receive FDA 510(k) clearance?
Peralta Stone Removal Catheter received FDA 510(k) clearance on 2019-07-18, under 510(k) number K190492.
Who is the listed applicant for Peralta Stone Removal Catheter?
The FDA 510(k) record lists Calcula Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Peralta Stone Removal Catheter?
The FDA product code for Peralta Stone Removal Catheter is FFL.
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：FFL）
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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