FDA 510(k)

RAP 髂股靜脈針管

K 號：K250283 · 2025-07-10

決定日期2025-07-10

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

RAP Femoral Venous Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is LivaNova USA, Inc.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) number K250283. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RAP Femoral Venous Cannulae?

RAP Femoral Venous Cannulae is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is LivaNova USA, Inc.. The 510(k) number is K250283.

When did RAP Femoral Venous Cannulae receive FDA 510(k) clearance?

RAP Femoral Venous Cannulae received FDA 510(k) clearance on 2025-07-10, under 510(k) number K250283.

Who is the listed applicant for RAP Femoral Venous Cannulae?

The FDA 510(k) record lists LivaNova USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAP Femoral Venous Cannulae?

The FDA product code for RAP Femoral Venous Cannulae is DWF.

其他以 LivaNova USA, 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。

K250937靜脈回流針管 K233702SMARxT 管道及接頭

相關器械（代碼：DWF）

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。

K260195延長式單件動脈（EOPA）3D™ 運動脈管Medtronic, Inc.K250937靜脈回流針管LivaNova USA, Inc.K260043智能反應器迷彩塗層循環離身心肺管路組（SR180C）Smart Reactors K253203後向冠狀動脈 sinus 灌注針管Medtronic, Inc.K253671雙階段靜脈針管Sorin Group Italia S.R.L.K253998清晰視內冠狀動脈分流器Medtronic, Inc.

官方來源

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