AC3 系列經主动脉氣囊泵 (IABP)
K 號：K192238 · 2019-11-12
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器材摘要
AC3 Series Intra-Aortic Balloon Pump (IABP) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Teleflex. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192238. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AC3 Series Intra-Aortic Balloon Pump (IABP)?
AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Arrow International, Teleflex. The 510(k) number is K192238.
When did AC3 Series Intra-Aortic Balloon Pump (IABP) receive FDA 510(k) clearance?
AC3 Series Intra-Aortic Balloon Pump (IABP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192238.
Who is the listed applicant for AC3 Series Intra-Aortic Balloon Pump (IABP)?
The FDA 510(k) record lists Arrow International, Teleflex as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP)?
The FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP) is DSP.
相關臨床試驗
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相關器械（代碼：DSP）
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。
K250542AC3™ 系列經主动脉氣囊泵Arrow International, LLCK232343AC3™ 系列IABPArrow International, LLCK201112AC3 IABP，AC3 Optimus IABP，AutoCAT2 Wave IABP，AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix 體內動脈球囊針套件Arrow International, Inc.K190101超靈活IABArrow International, Inc.K190117光纖視覺內視鏡系統Arrow International, Inc.
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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