FDA 510(k)

索爾-貼心安全血液採集針（含/不含預裝夾子）

K 號：K163073 · 2017-05-19

決定日期2017-05-19

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K163073. 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 Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K163073.

When did Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder receive FDA 510(k) clearance?

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder received FDA 510(k) clearance on 2017-05-19, under 510(k) number K163073.

Who is the listed applicant for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

FDA 510(k) 記錄將 Sol-Millennium Medical, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder?

The FDA product code for Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder is JKA.

其他以 Sol-Millennium Medical, Inc. 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。

K252184SOL-M 輪狀釋放針筒配可交換針盤 K253110溶滑安全針；溶滑安全針搭配針筒 K250907索爾-保護TM XtraThin 安全拉環血液收集套件 K242291SOL-M Luer Lock 静脈注射器（低死腔）無針頭，SOL-M 滑尖注射器（低死腔）無針頭，SOL-M Luer Lock 静脈注射器（低死腔）可更換針頭，SOL-CARE Luer Lock 静脈注射器（低死腔）配安全針，SOL-M 滑尖注射器（低死腔）可更換針頭 K242099Sol-M™ 無針滑尖針筒，Sol-M™ 非對稱尖針筒無針 K241821Luer Lock 鋼針注射器；可更換針頭的 Luer Lock 注射器；鈍頭充填針的 Luer Lock 注射器

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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™ 安全滑動血液收集套組CMT Health PTE., Ltd.K252899女性培養設備；男性培養設備；傳送設備；進入設備Zhejiang 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 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管Becton, Dickinson and Company

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。