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FDA 510(k)

VANGUARD 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）

K号: K250150 · 2025-05-30

申请人Sorin Group Italia S.R.L.
决定日期2025-05-30
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

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250150. 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 VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)?

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K250150.

When did VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) receive FDA 510(k) clearance?

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250150.

Who is the listed applicant for VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)?

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

What is the FDA product code for VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)?

The FDA product code for VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) is DTR.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Sorin Group Italia 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。

K253671双阶段静脉导管K251783Inspire HCR和HCR DUAL心脏切开储液器K253616ProtekDilate 血管通路套件K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K243264DHF 0.2 血液浓缩器（DHF 02）；DHF 0.6 血液浓缩器（DHF 06）；SH 14 血液浓缩器（SH 14）K242953KIDS动脉过滤器

查看所有 24 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.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.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）MedtronicK223879Quantum 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.LK212688Quantum 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 →

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。

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