FDA 510(k)

PM2+系统及SmartPICC导管

K号: K243484 · 2025-05-29

决定日期2025-05-29

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

PM2+ System and SmartPICC Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K243484. 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 PM2+ System and SmartPICC Stylet?

PM2+ System and SmartPICC Stylet is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Piccolo Medical, Inc.. The 510(k) number is K243484.

When did PM2+ System and SmartPICC Stylet receive FDA 510(k) clearance?

PM2+ System and SmartPICC Stylet received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243484.

Who is the listed applicant for PM2+ System and SmartPICC Stylet?

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

What is the FDA product code for PM2+ System and SmartPICC Stylet?

The FDA product code for PM2+ System and SmartPICC Stylet is LJS.

列明Piccolo Medical, 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。

K252792PM2®系统及ECGuide®连接器 K240486PM2系统及ECGuide连接器 K200037Piccolo 医疗 SmartPICC 系统

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 Technologies K252373BioFlo 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 Vascular K252792PM2®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.K241587飞行员TLSVygon Corporation

官方来源

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