FDA 510(k)

Emerge單軌PTCA擴張針管

K 號：K220629 · 2022-03-24

決定日期2022-03-24

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Emerge Monorail PTCA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220629. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Emerge Monorail PTCA Dilatation Catheter?

Emerge Monorail PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Boston Scientific. The 510(k) number is K220629.

When did Emerge Monorail PTCA Dilatation Catheter receive FDA 510(k) clearance?

Emerge Monorail PTCA Dilatation Catheter received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220629.

Who is the listed applicant for Emerge Monorail PTCA Dilatation Catheter?

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 Emerge Monorail PTCA Dilatation Catheter?

The FDA product code for Emerge Monorail PTCA Dilatation Catheter is LOX.

其他以 Boston Scientific 為申請人之記錄

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相關器械（代碼：LOX）

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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