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FDA 510(k)

Vaccess™ CT 低轮廓电力注射植入式端口；Vaccess™ CT 电力注射植入式端口；PowerPort™ duo M.R.I.™ 植入式端口

K号: K252478 · 2025-09-05

申请人Bard Access Systems, Inc.
决定日期2025-09-05
产品代码LJT
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K252478. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port?

Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K252478.

When did Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port receive FDA 510(k) clearance?

Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port received FDA 510(k) clearance on 2025-09-05, under 510(k) number K252478.

Who is the listed applicant for Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port?

The FDA product code for Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port is LJT.

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Bard Access Systems, 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。

K251253PowerPort® isp 植入式端口；PowerPort® 超薄植入式端口；PowerPort® M.R.I.® 植入式端口；PowerPort® M.R.I.® isp 植入式端口K241353PowerLoc™ Max 动力注射输液套件；SafeStep™ Huber 针头套件K242328PowerPort® ClearVUE® 超薄植入式端口和PowerPort® ClearVUE® 超薄植入式端口K240146BD Prevue™ II 周围血管通路系统K222232Sherlock 3CG® 提位系统 (TPS) 针头/T-Lock 组装K210264BD PowerPiCC 导管

查看所有 7 个设备 →

相关器械（代码：LJT）

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。

K260916FLEXI-PORT® 动力注射植入式端口Portal Access, Inc.K251253PowerPort® isp 植入式端口；PowerPort® 超薄植入式端口；PowerPort® M.R.I.® 植入式端口；PowerPort® M.R.I.® isp 植入式端口Bard Access Systems, Inc.K242328PowerPort® ClearVUE® 超薄植入式端口和PowerPort® ClearVUE® 超薄植入式端口Bard Access Systems, Inc.K232737PowerPort® ClearVUE® 超薄心电图植入式端口；PowerPort® ClearVUE® isp 心电图植入式端口；PowerPort® isp M.R.I.® 心电图植入式端口；PowerPort® 超薄心电图植入式端口Bard Peripheral Vascular, Inc.K190559SmartPort+植入式端口，SmartPort塑料植入式端口AngioDynamics, Inc.K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.

官方来源

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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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