FDA 510(k)

AC3 IABP，AC3 Optimus IABP，AutoCAT2 Wave IABP，AutoCAT2 IABP

K 號：K201112 · 2020-05-27

決定日期2020-05-27

產品代碼DSP

諮詢委員會履歷

決定相當於

器材摘要

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K201112. 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 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Arrow International, Inc.. The 510(k) number is K201112.

When did AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP receive FDA 510(k) clearance?

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP received FDA 510(k) clearance on 2020-05-27, under 510(k) number K201112.

Who is the listed applicant for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

The FDA 510(k) record lists Arrow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP?

The FDA product code for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP is DSP.

其他以 Arrow International, Inc. 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。

K200634Arrow FiberOptix 體內動脈球囊針套件 K190101超靈活IAB K190117光纖視覺內視鏡系統 K162820AC3 系列IABP系統

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, LLC K232343AC3™ 系列IABPArrow International, LLC K200634Arrow FiberOptix 體內動脈球囊針套件Arrow International, Inc.K192238AC3 系列經主动脉氣囊泵 (IABP)Arrow International, Teleflex K190101超靈活IABArrow International, Inc.K190117光纖視覺內視鏡系統Arrow International, Inc.

官方來源

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