FDA 510(k)

LifeSPARC 泵，LifeSPARC 控制器

K号: K183623 · 2019-07-09

决定日期2019-07-09

产品代码KFM

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

LifeSPARC Pump, LifeSPARC 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 2019-07-09 under 510(k) number K183623. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LifeSPARC Pump, LifeSPARC Controller?

LifeSPARC Pump, LifeSPARC Controller is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K183623.

When did LifeSPARC Pump, LifeSPARC Controller receive FDA 510(k) clearance?

LifeSPARC Pump, LifeSPARC Controller received FDA 510(k) clearance on 2019-07-09, under 510(k) number K183623.

Who is the listed applicant for LifeSPARC Pump, LifeSPARC 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 LifeSPARC Pump, LifeSPARC Controller?

The FDA product code for LifeSPARC Pump, LifeSPARC Controller is KFM.

列明Cardiacassist, 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。

K233736LifeSPARC 系统 K232480ProtekDuo 静脉-静脉导管套装 K232132LifeSPARC 系统 K211830LifeSPARC 系统 K202751TandemHeart 泵和 Escort 控制器 K181150ProtekDuo 微型静脉-静脉导管套装

查看所有 11 个设备 →

相关器械（代码：KFM）

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。

K251762Quantum 灌注离心血泵 CP20NG 集成传感器（CP20V-NG）Spectrum Medical S.R.L.K250326Quantum 灌注离心血泵 CP22NG 集成传感器（CP22V-NG）Spectrum Medical S.R.L.K233091Quantum 灌注离心血泵 CP37 集成传感器（CP37V-VT）；Quantum 灌注离心血泵 CP22 集成传感器（CP22V-VT）Qura S.R.L K232132LifeSPARC 系统Cardiacassist, Inc.K220842Quantum 灌注离心血泵 CP22 集成传感器，Quantum 灌注离心血泵 CP20 集成传感器Qura S.R.L K200091Capiox iCP 离心泵Terumo Cardiovascular Systems Corporation

官方来源

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