FDA 510(k)

BD Vacutainer® Eclipse™ 血液采集针

K号: K243207 · 2025-07-03

决定日期2025-07-03

产品代码JKA

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

BD Vacutainer® Eclipse™ Blood Collection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K243207. 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 BD Vacutainer® Eclipse™ Blood Collection Needle?

BD Vacutainer® Eclipse™ Blood Collection Needle is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K243207.

When did BD Vacutainer® Eclipse™ Blood Collection Needle receive FDA 510(k) clearance?

BD Vacutainer® Eclipse™ Blood Collection Needle received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243207.

Who is the listed applicant for BD Vacutainer® Eclipse™ Blood Collection Needle?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Vacutainer® Eclipse™ Blood Collection Needle?

The FDA product code for BD Vacutainer® Eclipse™ Blood Collection Needle is JKA.

列明Becton, Dickinson and Company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。

K262163BD BBL Mueller Hinton II 肉汤（阳离子调整型）；BD Difco Mueller Hinton 肉汤 K260128BD Preset™ 和 BD A-Line™ 动脉血采集注射器 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 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 K260184Onclarity® Self-Collection Kit K252040BD Vacutainer® 血浆分离管 (PST™), BD Vacutainer® 乙二胺四乙酸二钠血样采集管

查看所有 102 个设备 →

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™ 安全滑动采血套装CMT 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

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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。