FDA 510(k)

VPS Rhythm DLX 裝置，配備 TipTracker 技術

K 號：K220363 · 2022-08-22

申請人Arrow International, LLC (A subsidiary of Teleflex, Inc.)

決定日期2022-08-22

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

VPS Rhythm DLX Device with TipTracker Technology is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K220363. 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 VPS Rhythm DLX Device with TipTracker Technology?

VPS Rhythm DLX Device with TipTracker Technology is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K220363.

When did VPS Rhythm DLX Device with TipTracker Technology receive FDA 510(k) clearance?

VPS Rhythm DLX Device with TipTracker Technology received FDA 510(k) clearance on 2022-08-22, under 510(k) number K220363.

Who is the listed applicant for VPS Rhythm DLX Device with TipTracker Technology?

The FDA 510(k) record lists Arrow International, LLC (A subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VPS Rhythm DLX Device with TipTracker Technology?

The FDA product code for VPS Rhythm DLX Device with TipTracker Technology is LJS.

其他以 Arrow International, LLC (A subsidiary of Teleflex, 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。

K243599Arrow™ Endurance™ 延長停留周邊導管系統 (EDC-00818)K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)K220280Arrow Stiffening Stylet

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 Technologies 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.

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。