FDA 510(k)

BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管

K 號：K252040 · 2026-03-13

決定日期2026-03-13

產品代碼JKA

諮詢委員會CH

決定Substantially Equivalent

器材摘要

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.

常見問題

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.

其他以 Becton, Dickinson and Company 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒 K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器 K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管 K260184Onclarity™ Self-Collection Kit K2508840.9 % 钠鹽注射劑，USP，BD PosiFlush™ SP 静脈注射針

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相關器械（代碼：JKA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒Becton, Dickinson and Company K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管Becton, Dickinson and Company K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器Becton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

官方來源

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