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FDA 510(k)

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

K 號：K222873 · 2022-11-07

申請人Medtronic
決定日期2022-11-07
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222873. 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 Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system?

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Medtronic. The 510(k) number is K222873.

When did Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system receive FDA 510(k) clearance?

Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222873.

Who is the listed applicant for Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system?

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

What is the FDA product code for Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system?

The FDA product code for Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system is DQY.

相關臨床試驗

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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其他以 Medtronic 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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLCK262240SSPC NXT 輸送導管CenterPoint Systems, LLCK261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLCK261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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