FDA 510(k)

Quantum 灌注离心血泵 CP20NG 集成传感器（CP20V-NG）

K号: K251762 · 2025-08-04

决定日期2025-08-04

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

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2025-08-04 under 510(k) number K251762. 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 Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K251762.

When did Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) receive FDA 510(k) clearance?

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) received FDA 510(k) clearance on 2025-08-04, under 510(k) number K251762.

Who is the listed applicant for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA 510(k) record lists Spectrum Medical S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is KFM.

列明Spectrum Medical S.R.L.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。

K240934Quantum 灌注血氧器 ECC VT160-E3（VT160-E3）；Quantum 灌注血氧器 ECC VT200-E3（VT200-E3）；Quantum 灌注血氧器 VT75-E3（VT75-E3）；K252541Quantum PureFlow 标准热交换器中流量 1/4 W K250326Quantum 灌注离心血泵 CP22NG 集成传感器（CP22V-NG）K241206Quantum 灌注混合系统 K241248Quantum 灌注双腔导管 31F-V1（DL31F-V1）

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。

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 K201320Quantum PureFlow 离心血泵 CP22 集成传感器Qura S.R.L

官方来源

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