FDA 510(k)

HI-TORQUE InfilTrac 導引絲系列

K 號：K193126 · 2019-12-11

決定日期2019-12-11

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

HI-TORQUE InfilTrac Guide Wire Family is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K193126. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HI-TORQUE InfilTrac Guide Wire Family?

HI-TORQUE InfilTrac Guide Wire Family is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Abbott Vascular. The 510(k) number is K193126.

When did HI-TORQUE InfilTrac Guide Wire Family receive FDA 510(k) clearance?

HI-TORQUE InfilTrac Guide Wire Family received FDA 510(k) clearance on 2019-12-11, under 510(k) number K193126.

Who is the listed applicant for HI-TORQUE InfilTrac Guide Wire Family?

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

What is the FDA product code for HI-TORQUE InfilTrac Guide Wire Family?

The FDA product code for HI-TORQUE InfilTrac Guide Wire Family is DQX.

其他以 Abbott Vascular 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。

K220634NC TREK NEO 冠狀擴張導管 K221057Viatrac 14 Plus 頸動脈擴張針管 K201834HI-TORQUE PROCEED 線導管系列 K200144高扭矩鋼芯裸導引絲 K191173Emboshield NAV6 體內栓子防護系統，裸線過濾導線 K180040NC TREK™ RX 冠狀動脈擴張導管；NC TREK™ OTW 冠狀動脈擴張導管；TREK™ RX 冠狀動脈擴張導管；TREK™ OTW 冠狀動脈擴張導管；MINI TREK™ RX 冠狀動脈擴張導管；MINI TREK™ OTW 冠狀動脈擴張導管；MINI TREK™ II OTW 冠狀動脈擴張導管

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相關器械（代碼：DQX）

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。

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官方來源

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