FDA 510(k)

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

K号: K201112 · 2020-05-27

决定日期2020-05-27

产品代码DSP

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Arrow International, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K200634Arrow FiberOptix 主动脉球囊导管套装 K190101UltraFlex IAB K190117Fiberoptix IAB K162820AC3 系列IABP 系统

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