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FDA 510(k)

3F 单腔和 4F 双腔 PowerPICC Provena 针管；3F 单腔和 4F 双腔 PowerPICC Provena 针管带有 SOLO 阀门技术

K号: K180548 · 2018-04-26

申请人C.R. Bard, Inc (Bard Has Joined Bd)
决定日期2018-04-26
产品代码LJS
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

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc (Bard Has Joined Bd). It received FDA 510(k) clearance on 2018-04-26 under 510(k) number K180548. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology?

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology is a medical device that received FDA 510(k) clearance on 2018-04-26. The listed applicant is C.R. Bard, Inc (Bard Has Joined Bd). The 510(k) number is K180548.

When did 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology receive FDA 510(k) clearance?

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology received FDA 510(k) clearance on 2018-04-26, under 510(k) number K180548.

Who is the listed applicant for 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology?

The FDA 510(k) record lists C.R. Bard, Inc (Bard Has Joined Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology?

The FDA product code for 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology is LJS.

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：LJS）

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。

K260929Neonav ECG 插针定位系统Navi Medical TechnologiesK252373BioFlo 混合 PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术；BioFlo 中线导管；Xcela 注射式 PICC；Xcela PICC 配有 PASV 阀技术；Xcela 混合 PICC 配有 PASV 阀技术Spectrum VascularK252792PM2®系统及ECGuide®连接器Piccolo Medical, Inc.K243458HydroPICC 4Fr 单腔标记导管，130 cm 导丝 - 基础套装 (70001301)；HydroPICC 4Fr 单腔标记导管，70 cm 导丝 - 基础套装 (70001302)；HydroPICC 4Fr 单腔标记导管 - 最大屏障套装 (70001304)；HydroPICC 5Fr 双腔标记导管，130 cm 导丝 - 基础套装 (70002301)；HydroPICC 5Fr 双腔标记导管，70 cm 导丝 - 基础套装 (70002302)；HydroPICC 5Fr 双腔标记导管 - 最大屏障套装 (70002304)；HydrAccess Vascular, Inc.K251212双腔5Fr HydroPICC导管（PICC-251CM）（PICC-251CM）；双腔5Fr HydroPICC导管（PICC-252CM）（PICC-252CM）Access Vascular, Inc.K243484PM2+系统及SmartPICC导管Piccolo Medical, Inc.

官方来源

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