FDA 510(k)

TruSelect™ 2.6 微导管

K 號：K260771 · 2026-05-15

決定日期2026-05-15

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

TruSelect™ 2.6 Microcatheter 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 2026-05-15 under 510(k) number K260771. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TruSelect™ 2.6 Microcatheter?

TruSelect™ 2.6 Microcatheter is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Boston Scientific Corporation. The 510(k) number is K260771.

When did TruSelect™ 2.6 Microcatheter receive FDA 510(k) clearance?

TruSelect™ 2.6 Microcatheter received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260771.

Who is the listed applicant for TruSelect™ 2.6 Microcatheter?

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 TruSelect™ 2.6 Microcatheter?

The FDA product code for TruSelect™ 2.6 Microcatheter is KRA.

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：KRA）

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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