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FDA 510(k)

生物飛萊混合型PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術及PASV閥技術；生物飛萊PICC配備ENDEXO技術；生物飛萊中線針管；Xcela電漿注射型PICC；Xcela PICC配備PASV閥技術；Xcela混合型PICC配備PASV閥技術

K 號：K252373 · 2025-12-16

申請人Spectrum Vascular
決定日期2025-12-16
產品代碼LJS
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

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252373. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology?

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Spectrum Vascular. The 510(k) number is K252373.

When did BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology receive FDA 510(k) clearance?

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252373.

Who is the listed applicant for BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology?

FDA 510(k) 記錄將 Spectrum Vascular 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology?

The FDA product code for BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology is LJS.

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 Spectrum Vascular 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。

K260165未浸潤中心靜脈針管K261455動脈壓力監測組/托盤K254278動脈壓力監測組/托盤K250724骨內輸液針K241115SV Spectrum MRC中心靜脈針；SV Spectrum MR中心靜脈針；SV中心靜脈針

相關器械（代碼：LJS）

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。

K260929Neonav 心電圖針定位系統Navi Medical TechnologiesK252792PM2™ 系統搭配 ECGuide™ 接頭Piccolo Medical, Inc.K243458HydroPICC 4Fr單腔標記針管，130 cm導絲 - 基本套件（70001301）；HydroPICC 4Fr單腔標記針管，70 cm導絲 - 基本套件（70001302）；HydroPICC 4Fr單腔標記針管 - 极限屏障套件（70001304）；HydroPICC 5Fr雙腔標記針管，130 cm導絲 - 基本套件（70002301）；HydroPICC 5Fr雙腔標記針管，70 cm導絲 - 基本套件（70002302）；HydroPICC 5Fr雙腔標記針管 - 极限屏障套件（70002304）；HydrAccess Vascular, Inc.K251212雙腔道 5Fr HydroPICC 穿刺針 (PICC-251CM) (PICC-251CM)；雙腔道 5Fr HydroPICC 穿刺針 (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+系統及SmartPICC針筒Piccolo Medical, Inc.K241587飛行員TLSVygon Corporation

官方來源

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