FDA 510(k)

Steripath® Flow® 血液采集系统

K号: K251812 · 2025-09-25

决定日期2025-09-25

产品代码JKA

咨询委员会CH

决定Substantially Equivalent

器械摘要

Steripath® Flow™ Blood Collection System is the device name listed in this FDA 510(k) record. The listed applicant is Magnolia Medical Technologies. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251812. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Steripath® Flow™ Blood Collection System?

Steripath® Flow™ Blood Collection System is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Magnolia Medical Technologies. The 510(k) number is K251812.

When did Steripath® Flow™ Blood Collection System receive FDA 510(k) clearance?

Steripath® Flow™ Blood Collection System received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251812.

Who is the listed applicant for Steripath® Flow™ Blood Collection System?

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

What is the FDA product code for Steripath® Flow™ Blood Collection System?

The FDA product code for Steripath® Flow™ Blood Collection System is JKA.

列明Magnolia Medical Technologies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。

K222299Steripath 微型血液采集系统

相关器械（代码：JKA）

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。

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899女性培养装置；男性培养装置；转移装置；接入装置Zhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ 和 BD A-Line™ 动脉血采集注射器Becton, Dickinson and Company K252506BD Vacutainer® 安全锁定® 血样采集套装; BD Vacutainer® 安全锁定® 血样采集套装带预装夹具Becton, Dickinson and Company K252378BD® MiniDraw™ 细胞毛细管血样采集系统带 BD® MiniDraw™ SST™ 细胞毛细管血样采集管Becton, Dickinson and Company K252040BD Vacutainer® 血浆分离管 (PST™), BD Vacutainer® 乙二胺四乙酸二钠血样采集管Becton, Dickinson and Company

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。