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FDA 510(k)

MEDRAD Stellant FLEX CT 注射系统带 Certegra 工作站，MEDRAD Stellant FLEX 注射器套件，MEDRAD Stellant CT 注射系统带 Certegra 工作站，MEDRAD Stellant 注射器套件，MEDRAD Stellant 连接管，P3T 心脏，P3T 肺动脉，P3T 腹部，ISI，Connect.CT

K号: K182273 · 2018-11-01

申请人Bayer Medical Care, Inc.
决定日期2018-11-01
产品代码DXT
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

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K182273. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K182273.

When did MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT receive FDA 510(k) clearance?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182273.

Who is the listed applicant for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT?

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

What is the FDA product code for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT?

The FDA product code for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT is DXT.

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Bayer Medical Care, Inc.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。

K253688MEDRAD® 成像大批量包装转移针头K252891MEDRAD MRXperion MR 注射系统及 MR 注射系统注射器套件；MEDRAD ISI2 模块（ISI2）K250893球关节引导阵列（66295）K200280MEDRAD 成像大批量包装转移针头K192370MEDRAD Stellant FLEX CT 注射系统带 Certegra 工作站K193028MEDRAD Mark 7 Arterion 注射系统

查看所有 9 个设备 →

相关器械（代码：DXT）

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。

K252652用于电力注射器的配套一次性注射器（900103T）；用于电力注射器的配套一次性注射器（900103H）；用于电力注射器的配套一次性注射器（801800H）；用于电力注射器的配套一次性注射器（800099T）；用于电力注射器的配套一次性注射器（800099H）；用于电力注射器的配套一次性注射器（800096T）；用于电力注射器的配套一次性注射器（800096H）；一次性注射器配套Fortis Biosolutions Company LimitedK252638VeraPro S100 多功能注射器（018808）；VeraPro S100 LV1 低粘度一次性注射器（018811）；VeraPro AMT 自动分路器和传感器（018814）；VeraPro AngioTouch FLX165 手控器套件（018806）；VeraPro AngioTouch HiFi165 手控器套件（018804）Acist Medical Systems, Inc.K252653ACIST Pro 诊断系统 (019304)；处理单元床架；AngioTouch 模块；ACIST Pro 手推车；单探头电缆；三探头电缆Acist Medical Systems, Inc.K253048高压注射器；压力连接管；快速填充管；针头；转移管Shenzhen Maiwei Biotech Co., Ltd.K251788扩展管Zhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR 注射系统及 MR 注射系统注射器套件；MEDRAD ISI2 模块（ISI2）Bayer Medical Care, Inc.

官方来源

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