FDA 510(k)

TriSalus TriNav® LV 灌注系統

K 號：K230957 · 2023-05-02

決定日期2023-05-02

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

TriSalus TriNav® LV Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Trisalus Life Sciences. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230957. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TriSalus TriNav® LV Infusion System?

TriSalus TriNav® LV Infusion System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Trisalus Life Sciences. The 510(k) number is K230957.

When did TriSalus TriNav® LV Infusion System receive FDA 510(k) clearance?

TriSalus TriNav® LV Infusion System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230957.

Who is the listed applicant for TriSalus TriNav® LV Infusion System?

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

What is the FDA product code for TriSalus TriNav® LV Infusion System?

The FDA product code for TriSalus TriNav® LV Infusion System is KRA.

其他以 Trisalus Life Sciences 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。

K253509TriSalus TriNav 先進輸液系統 K233858TriSalus TriGuide™ 引導心导管 K193107TriSalus 靜脈輸注系統

相關器械（代碼：KRA）

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。

K253509TriSalus TriNav 先進輸液系統Trisalus Life Sciences K254051導入式輸液針管系統SmartWise Sweden AB K261610Verge™ 微导管Instylla, Inc.K260771TruSelect™ 2.6 微导管Boston Scientific Corporation K250794InVera 靜脈輸注設備Invera Medical K243534微導管Suzhou Zenith Vascular SciTech Limited

官方來源

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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。