FDA 510(k)

Capiox iCP 离心泵

K号: K200091 · 2021-11-18

申请人Terumo Cardiovascular Systems Corporation

决定日期2021-11-18

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

Capiox iCP Centrifugal Pump is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K200091. 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 Capiox iCP Centrifugal Pump?

Capiox iCP Centrifugal Pump is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K200091.

When did Capiox iCP Centrifugal Pump receive FDA 510(k) clearance?

Capiox iCP Centrifugal Pump received FDA 510(k) clearance on 2021-11-18, under 510(k) number K200091.

Who is the listed applicant for Capiox iCP Centrifugal Pump?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capiox iCP Centrifugal Pump?

The FDA product code for Capiox iCP Centrifugal Pump is KFM.

列明Terumo Cardiovascular Systems Corporation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。

K234065CDI OneView 监控系统 K221895Terumo 先进灌注系统 1 K182110CDI 血液参数监测系统 550 K180950Terumo Capiox NX19 储液式氧合器（东向），Terumo Capiox NX19 储液式氧合器（西向），Terumo Capiox NX19 氧合器（东向），Terumo Capiox NX19 氧合器（西向）K172071Terumo Capiox NX19 储液式氧合器（东向），Terumo Capiox NX19 储液式氧合器（西向），Terumo Capiox NX19 氧合器（东向），Terumo Capiox NX19 氧合器（西向）K172220高级灌注系统1

查看所有 10 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 K201320Quantum PureFlow 离心血泵 CP22 集成传感器Qura S.R.L

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。