FDA 510(k)

CrossFAST™ 集成微导管導引延伸系統 (CFM55)

K 號：K242276 · 2024-09-30

決定日期2024-09-30

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is the device name listed in this FDA 510(k) record. The listed applicant is Vantis Vascular, Inc.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K242276. 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 CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)?

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Vantis Vascular, Inc.. The 510(k) number is K242276.

When did CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) receive FDA 510(k) clearance?

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) received FDA 510(k) clearance on 2024-09-30, under 510(k) number K242276.

Who is the listed applicant for CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)?

FDA 510(k) 記錄將 Vantis Vascular, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)?

The FDA product code for CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is DQY.

其他以 Vantis Vascular, 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。

K262817CrossFAST整合式微导管先進輸送系統

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, LLC K262240SSPC NXT 輸送導管CenterPoint Systems, LLC K261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLC K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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