FDA 510(k)

Quantum 灌注混合系统

K号: K241206 · 2024-07-18

决定日期2024-07-18

产品代码DTN

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 Hybrid System 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 2024-07-18 under 510(k) number K241206. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Perfusion Hybrid System?

Quantum Perfusion Hybrid System is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K241206.

When did Quantum Perfusion Hybrid System receive FDA 510(k) clearance?

Quantum Perfusion Hybrid System received FDA 510(k) clearance on 2024-07-18, under 510(k) number K241206.

Who is the listed applicant for Quantum Perfusion Hybrid System?

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 Hybrid System?

The FDA product code for Quantum Perfusion Hybrid System is DTN.

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 K251762Quantum 灌注离心血泵 CP20NG 集成传感器（CP20V-NG）K250326Quantum 灌注离心血泵 CP22NG 集成传感器（CP22V-NG）K241248Quantum 灌注双腔导管 31F-V1（DL31F-V1）

相关器械（代码：DTN）

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。

K251783Inspire HCR和HCR DUAL心脏切开储液器Sorin Group Italia S.R.L.K241053MVR® 静脉储血袋 800 毫升；MVR® 静脉储血袋 1600 毫升；MVR® 静脉储血袋带 Cortiva® 生物活性表面 800 毫升；MVR® 静脉储血袋带 Cortiva® 生物活性表面 1600 毫升Medtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200，INSPIRE 6F C，INSPIRE 8F CSorin Group Italia S.R.L.

官方来源

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