FDA 510(k)

SuperCross 微导管，SuperCross FT 微导管，SuperCross AT 微导管

K 號：K210647 · 2021-04-30

決定日期2021-04-30

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210647. 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 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K210647.

When did SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter receive FDA 510(k) clearance?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210647.

Who is the listed applicant for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

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

What is the FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

The FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is DQY.

其他以 Vascular Solutions, LLC 為申請人之記錄

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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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