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FDA 510(k)

TandemHeart 泵和 Escort 控制器

K号: K202751 · 2021-03-26

申请人Cardiacassist, Inc.
决定日期2021-03-26
产品代码QNR
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

TandemHeart Pump and Escort Controller is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K202751. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TandemHeart Pump and Escort Controller?

TandemHeart Pump and Escort Controller is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K202751.

When did TandemHeart Pump and Escort Controller receive FDA 510(k) clearance?

TandemHeart Pump and Escort Controller received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202751.

Who is the listed applicant for TandemHeart Pump and Escort Controller?

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

What is the FDA product code for TandemHeart Pump and Escort Controller?

The FDA product code for TandemHeart Pump and Escort Controller is QNR.

相关临床试验

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NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cardiacassist, Inc.为申报人的其他记录

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相关器械（代码：QNR）

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。

K250199VitalFlow 控制台Medtronic, Inc.K234118CentriMag®急性循环支持系统ABBOTT MEDICALK233736LifeSPARC 系统Cardiacassist, Inc.K223898VitalFlow™ 离心泵Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K230364VitalFlow™ 控制台Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag®血泵，用于与CentriMag®急性循环支持系统一起使用Abbott (Formerly Thoratec Corporation)

官方来源

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