FDA 510(k)

維京™ 固定曲率診斷導管

K 號：K250310 · 2025-06-27

決定日期2025-06-27

產品代碼DRF

諮詢委員會履歷

決定相當於

器材摘要

VIKING™ Fixed Curve Diagnostic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250310. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VIKING™ Fixed Curve Diagnostic Catheter?

VIKING™ Fixed Curve Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Boston Scientific Corporation. The 510(k) number is K250310.

When did VIKING™ Fixed Curve Diagnostic Catheter receive FDA 510(k) clearance?

VIKING™ Fixed Curve Diagnostic Catheter received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250310.

Who is the listed applicant for VIKING™ Fixed Curve Diagnostic Catheter?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for VIKING™ Fixed Curve Diagnostic Catheter?

The FDA product code for VIKING™ Fixed Curve Diagnostic Catheter is DRF.

其他以 Boston Scientific Corporation 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：DRF）

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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