FDA 510(k)

Quantum 微型心肌保护输送系统；Quantum 微型心肌保护输送模块（QMCDM）

K号: K240908 · 2025-07-08

决定日期2025-07-08

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 Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-08 under 510(k) number K240908. 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 Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K240908.

When did Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) receive FDA 510(k) clearance?

Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) received FDA 510(k) clearance on 2025-07-08, under 510(k) number K240908.

Who is the listed applicant for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

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

What is the FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)?

The FDA product code for Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) is DTR.

列明Spectrum Medical , Ltd.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。

K212657Quantum 加热器-冷却器 K210669Quantum 微型通气模块 K202733Quantum 呼吸模块 K202557Quantum 工作站 12 Elite K192838Quantumn 中心血泵驱动-高压, Quantumn 中心血泵驱动-中压 K190282Quantum Smart Occluder LH (左手), Quantum Smart Occluder LH (右手)

查看所有 12 个设备 →

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.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 K212688Quantum PureFlow 标准热交换器, Quantum PureFlow 心肌停搏热交换器Qura S.R.L

官方来源

在 FDA 数据库中查看 →

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