FDA 510(k)

Neonav 心電圖針定位系統

K 號：K260929 · 2026-04-17

決定日期2026-04-17

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

Neonav ECG Tip Location System is the device name listed in this FDA 510(k) record. The listed applicant is Navi Medical Technologies. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K260929. 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 Neonav ECG Tip Location System?

Neonav ECG Tip Location System is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Navi Medical Technologies. The 510(k) number is K260929.

When did Neonav ECG Tip Location System receive FDA 510(k) clearance?

Neonav ECG Tip Location System received FDA 510(k) clearance on 2026-04-17, under 510(k) number K260929.

Who is the listed applicant for Neonav ECG Tip Location System?

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

What is the FDA product code for Neonav ECG Tip Location System?

The FDA product code for Neonav ECG Tip Location System is LJS.

其他以 Navi Medical Technologies 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。

K241910Neonav 心電圖針定位系統

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。

K252373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Spectrum Vascular K252792PM2™ 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

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。