FDA 510(k)

BD Vacutainer® 血浆分离管 (PST™), BD Vacutainer® 乙二胺四乙酸二钠血样采集管

K号: K252040 · 2026-03-13

决定日期2026-03-13

产品代码JKA

咨询委员会CH

决定Substantially Equivalent

器械摘要

BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes 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 2026-03-13 under 510(k) number K252040. 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® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes?

BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K252040.

When did BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes receive FDA 510(k) clearance?

BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252040.

Who is the listed applicant for BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes?

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® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes?

The FDA product code for BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes 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 Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth 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 K2508840.9%氯化钠注射剂，USP，BD PosiFlush® SP注射器

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™ 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 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 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 K251812Steripath® Flow® 血液采集系统Magnolia Medical Technologies

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。