FDA 510(k)

BD Preset™ 和 BD A-Line™ 动脈血液採集針筒

K 號：K260128 · 2026-04-15

決定日期2026-04-15

產品代碼JKA

諮詢委員會CH

決定Substantially Equivalent

器材摘要

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes 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 2026-04-15 under 510(k) number K260128. 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 Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K260128.

When did BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes receive FDA 510(k) clearance?

BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260128.

Who is the listed applicant for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

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 Preset™ and BD A-Line™ Arterial Blood Collection Syringes?

The FDA product code for BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes 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 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 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管 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.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 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管Becton, Dickinson and Company K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

官方來源

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