FDA 510(k)

Impella CP 引導器

K 號：K192769 · 2019-11-18

決定日期2019-11-18

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Impella CP Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2019-11-18 under 510(k) number K192769. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Impella CP Introducer?

Impella CP Introducer is a medical device that received FDA 510(k) clearance on 2019-11-18. The listed applicant is Abiomed, Inc.. The 510(k) number is K192769.

When did Impella CP Introducer receive FDA 510(k) clearance?

Impella CP Introducer received FDA 510(k) clearance on 2019-11-18, under 510(k) number K192769.

Who is the listed applicant for Impella CP Introducer?

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

What is the FDA product code for Impella CP Introducer?

The FDA product code for Impella CP Introducer is DYB.

其他以 Abiomed, Inc. 為申請人之記錄

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相關器械（代碼：DYB）

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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