FDA 510(k)

CG+ Arrow PICC由Arrow VPS Stylet PLUS和Arrow VPS Stylet PLUS供电

K号: K153487 · 2016-02-04

申请人Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

决定日期2016-02-04

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

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K153487. 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 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K153487.

When did CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS receive FDA 510(k) clearance?

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS received FDA 510(k) clearance on 2016-02-04, under 510(k) number K153487.

Who is the listed applicant for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA 510(k) record lists Arrow International, Inc. (Subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS?

The FDA product code for CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS is LJS.

列明Arrow International, Inc. (Subsidiary of Teleflex, 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。

K180395EZ-IO 骨髓内血管通路系统 K163513Arrow Endurance 扩展停留外周导管系统 K161313ARROW 压力注射式中线导管，配备 Chlorag+ard 抗菌和抗血栓形成技术 K160018Arrow Quickflash 动脉导管插入装置 K153423CG+ Arrow JACC由Arrow VPS Stylet供电，CG+ Arrow JACC

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.K243484PM2+系统及SmartPICC导管Piccolo Medical, Inc.

官方来源

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