FDA 510(k)

漢森醫療麥哲倫機械導管 9Fr

K 號：K160919 · 2016-09-20

決定日期2016-09-20

產品代碼DRA

諮詢委員會履歷

決定相當於

器材摘要

Hansen Medical Magellan Robotic Catheter 9Fr is the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical, Inc.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K160919. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hansen Medical Magellan Robotic Catheter 9Fr?

Hansen Medical Magellan Robotic Catheter 9Fr is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K160919.

When did Hansen Medical Magellan Robotic Catheter 9Fr receive FDA 510(k) clearance?

Hansen Medical Magellan Robotic Catheter 9Fr received FDA 510(k) clearance on 2016-09-20, under 510(k) number K160919.

Who is the listed applicant for Hansen Medical Magellan Robotic Catheter 9Fr?

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

What is the FDA product code for Hansen Medical Magellan Robotic Catheter 9Fr?

The FDA product code for Hansen Medical Magellan Robotic Catheter 9Fr is DRA.

其他以 Hansen Medical, Inc. 為申請人之記錄

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K153304漢森醫療麥哲倫機械導管電子套件

相關器械（代碼：DRA）

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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