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)

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices

K 號：K212525 · 2022-08-19

申請人Advcare Medical
決定日期2022-08-19
產品代碼LHI
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is the device name listed in this FDA 510(k) record. The listed applicant is Advcare Medical. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K212525. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Advcare Medical. The 510(k) number is K212525.

When did Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices receive FDA 510(k) clearance?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices received FDA 510(k) clearance on 2022-08-19, under 510(k) number K212525.

Who is the listed applicant for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

The FDA 510(k) record lists Advcare Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

The FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is LHI.

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

相關器械（代碼：LHI）

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。

K252987ADRx® 混合設備Epic Medical Pte. , Ltd.K260301藥劑適配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345美林袋式分酒器Medline Industries, LPK251715FlowArt® 輸液針筒進入設備 通氣Asset MedikalK251676Medline Microtek C-Flo Bag Decanter, 適用於無菌 (2000S)；Medline Microtek Bag Decanter II，適用於無菌 (2002S)；Medline Microtek Vial Decanter，適用於無菌 (2006S)；Medline Microtek Transfer Device，適用於無菌 (2008S)Microtek Medical, LLCK243404HyHub™ 及 HyHub™ Duo 藥劑針筒進入設備Takeda Pharmaceuticals

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。

↑