FDA 510(k)

超級 ICE Plus – PI 9 MHz 周邊成像導管

K 號：K181042 · 2018-05-17

決定日期2018-05-17

產品代碼DXK

諮詢委員會履歷

決定相當於

器材摘要

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-05-17 under 510(k) number K181042. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter?

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K181042.

When did Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter receive FDA 510(k) clearance?

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter received FDA 510(k) clearance on 2018-05-17, under 510(k) number K181042.

Who is the listed applicant for Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter?

The FDA product code for Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is DXK.

其他以 Boston Scientific Corporation 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。

K262151SpaceOAR Flex™ 系統 K261153LithoVue Elite數位柔軟輸尿管鏡系統 K261915導航™ Flex 腎管進入鞘組合 K262165FARADRIVE™操縱式鞘 (M004PF21M402)K262462TheraSphere 360™ Y-90 管理平台 K261488OBSIDIO 可調適性栓塊

查看所有 167 項裝置 →

相關器械（代碼：DXK）

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。

K160173超ICE Plus 9 MHz 門腔內心超聲導管(eDFU)，超ICE Plus 9 MHz 門腔內心超聲導管（紙質DFU）Boston Scientific 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。