087 機械導管系統
K 號：K192525 · 2019-10-31
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器材摘要
087 Balloon Guide Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, LLC. It received FDA 510(k) clearance on 2019-10-31 under 510(k) number K192525. 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 087 Balloon Guide Catheter System?
087 Balloon Guide Catheter System is a medical device that received FDA 510(k) clearance on 2019-10-31. The listed applicant is Q'Apel Medical, LLC. The 510(k) number is K192525.
When did 087 Balloon Guide Catheter System receive FDA 510(k) clearance?
087 Balloon Guide Catheter System received FDA 510(k) clearance on 2019-10-31, under 510(k) number K192525.
Who is the listed applicant for 087 Balloon Guide Catheter System?
The FDA 510(k) record lists Q'Apel Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 087 Balloon Guide Catheter System?
The FDA product code for 087 Balloon Guide Catheter System 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
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