091 機械導管
K 號：K231629 · 2023-10-31
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器材摘要
091 Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Eosolutions, Corp.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231629. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 091 Balloon Guide Catheter?
091 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Eosolutions, Corp.. The 510(k) number is K231629.
When did 091 Balloon Guide Catheter receive FDA 510(k) clearance?
091 Balloon Guide Catheter received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231629.
Who is the listed applicant for 091 Balloon Guide Catheter?
The FDA 510(k) record lists Eosolutions, Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 091 Balloon Guide Catheter?
The FDA product code for 091 Balloon Guide Catheter is DQY.
相關臨床試驗
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相關器械（代碼：DQY）
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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