FDA 510(k)

FlexiGo 3D 輸送導管

K 號：K250492 · 2025-06-18

決定日期2025-06-18

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

FlexiGo 3D Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K250492. 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 FlexiGo 3D Delivery Catheter?

FlexiGo 3D Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K250492.

When did FlexiGo 3D Delivery Catheter receive FDA 510(k) clearance?

FlexiGo 3D Delivery Catheter received FDA 510(k) clearance on 2025-06-18, under 510(k) number K250492.

Who is the listed applicant for FlexiGo 3D Delivery Catheter?

FDA 510(k) 記錄將 CenterPoint Systems, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FlexiGo 3D Delivery Catheter?

The FDA product code for FlexiGo 3D Delivery Catheter is DQY.

其他以 CenterPoint Systems, LLC 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。

K261766CPS 定位器 3D Plus 輸送导管 K262240SSPC NXT 輸送導管 K261492FieldFlex 經導鞘 K260942AuST Steerable Sheath K260163AuST CSP Introducer K250828CPS 定位器 3D Plus 輸送导管

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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, 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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