FDA 510(k)

EZ-IO 骨髓内血管通路系统

K号: K180395 · 2018-11-09

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

决定日期2018-11-09

产品代码FMI

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决定实质等同

器械摘要

EZ-IO Intraosseous Vascular Access System 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 2018-11-09 under 510(k) number K180395. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EZ-IO Intraosseous Vascular Access System?

EZ-IO Intraosseous Vascular Access System is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K180395.

When did EZ-IO Intraosseous Vascular Access System receive FDA 510(k) clearance?

EZ-IO Intraosseous Vascular Access System received FDA 510(k) clearance on 2018-11-09, under 510(k) number K180395.

Who is the listed applicant for EZ-IO Intraosseous Vascular Access System?

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 EZ-IO Intraosseous Vascular Access System?

The FDA product code for EZ-IO Intraosseous Vascular Access System is FMI.

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。

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 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

相关器械（代码：FMI）

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。

K261266MOWANA™ 自动双联PENTAMASTER MEDIQ SDN BHD K261719Promisemed X 安全笔式针头Promisemed Hangzhou Meditech Co., Ltd.K262427注射针（普通型I类，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全无菌皮下注射针（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ 双重安全笔式针头CMT Health PTE., Ltd.K260739Profoject™ 注射针（型号A；型号B）CMT Health PTE., Ltd.

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