FDA 510(k)

Verrata PLUS 压力導引針

K 號：K210235 · 2021-04-15

決定日期2021-04-15

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Verrata PLUS Pressure Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K210235. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Verrata PLUS Pressure Guide Wire?

Verrata PLUS Pressure Guide Wire is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Volcano Corporation. The 510(k) number is K210235.

When did Verrata PLUS Pressure Guide Wire receive FDA 510(k) clearance?

Verrata PLUS Pressure Guide Wire received FDA 510(k) clearance on 2021-04-15, under 510(k) number K210235.

Who is the listed applicant for Verrata PLUS Pressure Guide Wire?

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

What is the FDA product code for Verrata PLUS Pressure Guide Wire?

The FDA product code for Verrata PLUS Pressure Guide Wire is DQX.

其他以 Volcano Corporation 為申請人之記錄

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相關器械（代碼：DQX）

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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