FDA 510(k)

iSLEEVE 引導套件

K 號：K250468 · 2025-03-20

決定日期2025-03-20

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

iSLEEVE Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K250468. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iSLEEVE Introducer Set?

iSLEEVE Introducer Set is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Boston Scientific. The 510(k) number is K250468.

When did iSLEEVE Introducer Set receive FDA 510(k) clearance?

iSLEEVE Introducer Set received FDA 510(k) clearance on 2025-03-20, under 510(k) number K250468.

Who is the listed applicant for iSLEEVE Introducer Set?

FDA 510(k) 記錄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 iSLEEVE Introducer Set?

The FDA product code for iSLEEVE Introducer Set is DYB.

其他以 Boston Scientific 為申請人之記錄

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相關器械（代碼：DYB）

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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