FDA 510(k)

Captus 血管回收系統

K 號：K170987 · 2017-08-28

決定日期2017-08-28

產品代碼MMX

諮詢委員會履歷

決定相當於

器材摘要

Captus Vascular Retrieval System is the device name listed in this FDA 510(k) record. The listed applicant is Avantec Vascular Corporation. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K170987. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Captus Vascular Retrieval System?

Captus Vascular Retrieval System is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Avantec Vascular Corporation. The 510(k) number is K170987.

When did Captus Vascular Retrieval System receive FDA 510(k) clearance?

Captus Vascular Retrieval System received FDA 510(k) clearance on 2017-08-28, under 510(k) number K170987.

Who is the listed applicant for Captus Vascular Retrieval System?

The FDA 510(k) record lists Avantec Vascular Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Captus Vascular Retrieval System?

The FDA product code for Captus Vascular Retrieval System is MMX.

其他以 Avantec Vascular Corporation 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。

K251207桑格麗™ 靈活血栓切除系統

相關器械（代碼：MMX）

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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