FDA 510(k)

MEDRAD Stellant FLEX CT 注射系统带 Certegra 工作站

K号: K192370 · 2019-12-13

决定日期2019-12-13

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 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 2019-12-13 under 510(k) number K192370. 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 CT Injection System with Certegra Workstation is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K192370.

When did MEDRAD Stellant FLEX CT Injection System with Certegra Workstation receive FDA 510(k) clearance?

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192370.

Who is the listed applicant for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation?

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?

The FDA product code for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is DXT.

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 K193028MEDRAD Mark 7 Arterion 注射系统 K182273MEDRAD 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

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 Limited K252638VeraPro 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

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。