免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

血液採集套件、帶支架的血液採集套件、安全血液採集套件、帶支架的安全血液採集套件、血液

K 號：K230080 · 2023-07-07

申請人Yangzhou Medline Industry, Co., Ltd.
決定日期2023-07-07
產品代碼JKA
諮詢委員會CH
決定相當於

器材摘要

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Medline Industry, Co., Ltd.. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K230080. 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 Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood?

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Yangzhou Medline Industry, Co., Ltd.. The 510(k) number is K230080.

When did Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood receive FDA 510(k) clearance?

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood received FDA 510(k) clearance on 2023-07-07, under 510(k) number K230080.

Who is the listed applicant for Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood?

The FDA 510(k) record lists Yangzhou Medline Industry, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood?

The FDA product code for Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood is JKA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Yangzhou Medline Industry, Co., Ltd. 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。

K170651无菌一次性注射器配安全針、无菌一次性注射器配針、无菌一次性注射器、无菌一次性安全針、无菌一次性針

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 CompanyK252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管Becton, Dickinson and CompanyK252506BD 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 CompanyK252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管Becton, Dickinson and Company

官方來源

在 FDA 資料庫中查看 →

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。

↑