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FDA 510(k)

再處理PentaRay Nav eco 高密度地圖導管

K 號：K201806 · 2021-06-23

申請人Sterilmed Inc. (Johnson and Johnson)
決定日期2021-06-23
產品代碼MTD
諮詢委員會履歷
決定相當於

器材摘要

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed Inc. (Johnson and Johnson). It received FDA 510(k) clearance on 2021-06-23 under 510(k) number K201806. 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 Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter is a medical device that received FDA 510(k) clearance on 2021-06-23. The listed applicant is Sterilmed Inc. (Johnson and Johnson). The 510(k) number is K201806.

When did Reprocessed PentaRay Nav eco High-Density Mapping Catheter receive FDA 510(k) clearance?

Reprocessed PentaRay Nav eco High-Density Mapping Catheter received FDA 510(k) clearance on 2021-06-23, under 510(k) number K201806.

Who is the listed applicant for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

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

What is the FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter?

The FDA product code for Reprocessed PentaRay Nav eco High-Density Mapping Catheter is MTD.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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)MedtronicK241372Advisor™ HD 格子 X 映射導管，感測器啟用™ABBOTT MEDICALK231312PENTARAY® 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

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