FDA 510(k)

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K 號：K190117 · 2019-06-13

決定日期2019-06-13

產品代碼DSP

諮詢委員會履歷

決定相當於

器材摘要

Fiberoptix IAB 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 2019-06-13 under 510(k) number K190117. 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 Fiberoptix IAB?

Fiberoptix IAB is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Arrow International, Inc.. The 510(k) number is K190117.

When did Fiberoptix IAB receive FDA 510(k) clearance?

Fiberoptix IAB received FDA 510(k) clearance on 2019-06-13, under 510(k) number K190117.

Who is the listed applicant for Fiberoptix IAB?

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 Fiberoptix IAB?

The FDA product code for Fiberoptix IAB 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。

K201112AC3 IABP，AC3 Optimus IABP，AutoCAT2 Wave IABP，AutoCAT2 IABP K200634Arrow FiberOptix 體內動脈球囊針套件 K190101超靈活IAB 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 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.

官方來源

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