BioCardia 8.5 F Avance 可調向 引導器
K 號：K190941 · 2019-05-06
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器材摘要
BioCardia 8.5 F Avance Steerable lntroducer is the device name listed in this FDA 510(k) record. The listed applicant is Biocardia, Inc.. It received FDA 510(k) clearance on 2019-05-06 under 510(k) number K190941. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioCardia 8.5 F Avance Steerable lntroducer?
BioCardia 8.5 F Avance Steerable lntroducer is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Biocardia, Inc.. The 510(k) number is K190941.
When did BioCardia 8.5 F Avance Steerable lntroducer receive FDA 510(k) clearance?
BioCardia 8.5 F Avance Steerable lntroducer received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190941.
Who is the listed applicant for BioCardia 8.5 F Avance Steerable lntroducer?
The FDA 510(k) record lists Biocardia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioCardia 8.5 F Avance Steerable lntroducer?
The FDA product code for BioCardia 8.5 F Avance Steerable lntroducer is DYB.
相關臨床試驗
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相關器械（代碼：DYB）
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。
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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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