FDA 510(k)

AC3™ 系列IABP

K 號：K232343 · 2023-08-30

決定日期2023-08-30

產品代碼DSP

諮詢委員會履歷

決定相當於

器材摘要

AC3™ Series IABP is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K232343. 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 IABP?

AC3™ Series IABP is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Arrow International, LLC. The 510(k) number is K232343.

When did AC3™ Series IABP receive FDA 510(k) clearance?

AC3™ Series IABP received FDA 510(k) clearance on 2023-08-30, under 510(k) number K232343.

Who is the listed applicant for AC3™ Series IABP?

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

What is the FDA product code for AC3™ Series IABP?

The FDA product code for AC3™ Series IABP is DSP.

其他以 Arrow International, LLC 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。

K250542AC3™ 系列經主动脉氣囊泵 K222341Arrow 0.2 Micron Flat Filter, GVS

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 K201112AC3 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.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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