FDA 510(k)

Advisor HD 格子映射導管，感測器啟用

K 號：K172393 · 2018-04-23

決定日期2018-04-23

產品代碼MTD

諮詢委員會履歷

決定相當於

器材摘要

Advisor HD Grid Mapping Catheter, Sensor Enabled is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K172393. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advisor HD Grid Mapping Catheter, Sensor Enabled?

Advisor HD Grid Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K172393.

When did Advisor HD Grid Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?

Advisor HD Grid Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2018-04-23, under 510(k) number K172393.

Who is the listed applicant for Advisor HD Grid Mapping Catheter, Sensor Enabled?

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

What is the FDA product code for Advisor HD Grid Mapping Catheter, Sensor Enabled?

The FDA product code for Advisor HD Grid Mapping Catheter, Sensor Enabled is MTD.

其他以 St. Jude Medical, 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。

K163407確認Rx可植入心臟監護器（ICM）系統 K161171壓力導絲 X 導絲 K161102Nanostim 引導套件 K160716Nanostim 引入套件

相關器械（代碼：MTD）

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。

K261012OptiMap 管子 - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap 管子 - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433球體-9Dx 診斷導管 (AFR-00009)Medtronic K241372Advisor™ HD 格子 X 映射導管，感測器啟用™ABBOTT MEDICAL K231312PENTARAY® NAV ECO 高密度地圖導管，DECANAV® 地圖導管，帶有自動識別功能的 Webster® CS 領管，帶有 EZ Steer 技術的 Webster® CS 領管，帶有自動識別功能的 EZ Steer 技術 Webster® CS 領管Biosense Webster, Inc.K223666Ablacath™ 繪製導管Ablacon, Inc.

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。