FDA 510(k)

SOFIA EX 颅內支撐導管

K 號：K182602 · 2019-05-15

決定日期2019-05-15

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

SOFIA EX Intracranial Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182602. 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 SOFIA EX Intracranial Support Catheter?

SOFIA EX Intracranial Support Catheter is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is MicroVention, Inc.. The 510(k) number is K182602.

When did SOFIA EX Intracranial Support Catheter receive FDA 510(k) clearance?

SOFIA EX Intracranial Support Catheter received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182602.

Who is the listed applicant for SOFIA EX Intracranial Support Catheter?

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

What is the FDA product code for SOFIA EX Intracranial Support Catheter?

The FDA product code for SOFIA EX Intracranial Support Catheter is DQY.

其他以 MicroVention, Inc. 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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