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FDA 510(k)

FLEXI-PORT® 动力注射植入式端口

K号: K260916 · 2026-06-17

申请人Portal Access, Inc.
决定日期2026-06-17
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

FLEXI-PORT™ Power Injectable Implantable Port is the device name listed in this FDA 510(k) record. The listed applicant is Portal Access, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K260916. 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 FLEXI-PORT™ Power Injectable Implantable Port?

FLEXI-PORT™ Power Injectable Implantable Port is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Portal Access, Inc.. The 510(k) number is K260916.

When did FLEXI-PORT™ Power Injectable Implantable Port receive FDA 510(k) clearance?

FLEXI-PORT™ Power Injectable Implantable Port received FDA 510(k) clearance on 2026-06-17, under 510(k) number K260916.

Who is the listed applicant for FLEXI-PORT™ Power Injectable Implantable Port?

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

What is the FDA product code for FLEXI-PORT™ Power Injectable Implantable Port?

The FDA product code for FLEXI-PORT™ Power Injectable 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

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。

K252478Vaccess™ 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Bard Access Systems, 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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