雷諾瓦脊椎氣囊導管
K 號：K231340 · 2023-10-30
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器材摘要
Renova Spine Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biopsybell S.R.L.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K231340. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Renova Spine Balloon Catheter?
Renova Spine Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Biopsybell S.R.L.. The 510(k) number is K231340.
When did Renova Spine Balloon Catheter receive FDA 510(k) clearance?
Renova Spine Balloon Catheter received FDA 510(k) clearance on 2023-10-30, under 510(k) number K231340.
Who is the listed applicant for Renova Spine Balloon Catheter?
The FDA 510(k) record lists Biopsybell S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Renova Spine Balloon Catheter?
The FDA product code for Renova Spine Balloon Catheter is NDN.
相關臨床試驗
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其他以 Biopsybell S.R.L. 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：NDN）
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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