FDA 510(k)

Quantum PureFlow 标准热交换器, Quantum PureFlow 心肌停搏热交换器

K号: K212688 · 2022-01-10

决定日期2022-01-10

产品代码DTR

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 PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212688. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Qura S.R.L. The 510(k) number is K212688.

When did Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger receive FDA 510(k) clearance?

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212688.

Who is the listed applicant for Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

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

What is the FDA product code for Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger?

The FDA product code for Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger is DTR.

列明Qura 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。

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相关器械（代码：DTR）

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。

K252541Quantum PureFlow 标准热交换器中流量 1/4 WSpectrum Medical S.R.L.K240908Quantum 微型心肌保护输送系统；Quantum 微型心肌保护输送模块（QMCDM）Spectrum Medical , Ltd.K250150VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装）；VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装带分流）；VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装迷你版）Sorin Group Italia S.R.L.K240190MYOtherm XP 心肌停搏液输送系统（Cortiva 生物活性表面），MYOtherm XP 心肌停搏液输送系统（未涂层）Medtronic K223879Quantum PureFlow 标准热交换器 (HX11W-S2, HX11W-S1M 和 HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow 标准热交换器和 Quantum PureFlow 心肌停搏热交换器Qura S.R.L

官方来源

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