FDA 510(k)

Instylla 微导管

K 號：K200744 · 2020-04-21

決定日期2020-04-21

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Instylla Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Instylla, Inc.. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200744. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Instylla Microcatheter?

Instylla Microcatheter is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Instylla, Inc.. The 510(k) number is K200744.

When did Instylla Microcatheter receive FDA 510(k) clearance?

Instylla Microcatheter received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200744.

Who is the listed applicant for Instylla Microcatheter?

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

What is the FDA product code for Instylla Microcatheter?

The FDA product code for Instylla Microcatheter is KRA.

其他以 Instylla, 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：KRA）

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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