FDA 510(k)

Dorado™ PTA 擴張球囊心导管

K 號：K250219 · 2025-06-17

決定日期2025-06-17

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Dorado™ PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K250219. 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 Dorado™ PTA Balloon Dilatation Catheter?

Dorado™ PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K250219.

When did Dorado™ PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Dorado™ PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-06-17, under 510(k) number K250219.

Who is the listed applicant for Dorado™ PTA Balloon Dilatation Catheter?

FDA 510(k) 記錄將 Bard Peripheral 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 Dorado™ PTA Balloon Dilatation Catheter?

The FDA product code for Dorado™ PTA Balloon Dilatation Catheter is DQY.

其他以 Bard Peripheral 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。

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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。

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官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。