FDA 510(k)

漢森醫療麥哲倫機械導管電子套件

K 號：K153304 · 2016-02-01

決定日期2016-02-01

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 eKit 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 2016-02-01 under 510(k) number K153304. 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 eKit?

Hansen Medical Magellan Robotic Catheter eKit is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K153304.

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

Hansen Medical Magellan Robotic Catheter eKit received FDA 510(k) clearance on 2016-02-01, under 510(k) number K153304.

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

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 eKit?

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

其他以 Hansen Medical, Inc. 為申請人之記錄

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K160919漢森醫療麥哲倫機械導管 9Fr

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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