FDA 510(k)

奧德賽微導管

K 號：K170664 · 2017-11-09

決定日期2017-11-09

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Odyssey Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K170664. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Odyssey Micro Catheter?

Odyssey Micro Catheter is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Heraeus Medical Components, LLC. The 510(k) number is K170664.

When did Odyssey Micro Catheter receive FDA 510(k) clearance?

Odyssey Micro Catheter received FDA 510(k) clearance on 2017-11-09, under 510(k) number K170664.

Who is the listed applicant for Odyssey Micro Catheter?

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

What is the FDA product code for Odyssey Micro Catheter?

The FDA product code for Odyssey Micro Catheter is DQY.

其他以 Heraeus Medical Components, LLC 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。

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相關器械（代碼：DQY）

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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官方來源

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