FDA 510(k)

托克爾心內電極導管，獨奏家心內電極導管

K 號：K190132 · 2019-07-30

決定日期2019-07-30

產品代碼DRF

諮詢委員會履歷

決定相當於

器材摘要

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190132. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Medtronic. The 510(k) number is K190132.

When did Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter receive FDA 510(k) clearance?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190132.

Who is the listed applicant for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

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

What is the FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

The FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is DRF.

其他以 Medtronic 為申請人之記錄

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相關器械（代碼：DRF）

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。

K252794視覺-MR™ 診斷導管Imricor Medical Systems, Inc.K250590MAGiC Sweep™ EP描記電極导管Stereotaxis, Inc.K250310維京™ 固定曲率診斷導管Boston Scientific Corporation K240366EP•XT™ 雙向導向診斷導管；Dynamic Tip™ 雙向導向診斷導管；Dynamic XT™ 雙向導向診斷導管Boston Scientific Corporation K233900北歐卡 PV 冷卻地圖針Synaptic Medical Corporation K233397科西恩-10TM 診斷導管Medtronic, Inc.

官方來源

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