FDA 510(k)

ARROW 压力注射式中线导管，配备 Chlorag+ard 抗菌和抗血栓形成技术

K号: K161313 · 2016-08-24

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

决定日期2016-08-24

产品代码PND

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

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 2016-08-24 under 510(k) number K161313. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K161313.

When did ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology receive FDA 510(k) clearance?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology received FDA 510(k) clearance on 2016-08-24, under 510(k) number K161313.

Who is the listed applicant for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

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 ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

The FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is PND.

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 K160018Arrow Quickflash 动脉导管插入装置 K153487CG+ Arrow PICC由Arrow VPS Stylet PLUS和Arrow VPS Stylet PLUS供电 K153423CG+ Arrow JACC由Arrow VPS Stylet供电，CG+ Arrow JACC

官方来源

在 FDA 数据库中查看 →

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。