FDA 510(k)

OutFlo 鳩膝瓣擴張氣球針管

K 號：K241562 · 2025-03-11

決定日期2025-03-11

產品代碼OZT

諮詢委員會履歷

決定相當於

器材摘要

OutFlo Aortic Valve Dilatation Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Disa Medinotec. It received FDA 510(k) clearance on 2025-03-11 under 510(k) number K241562. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OutFlo Aortic Valve Dilatation Balloon Catheter?

OutFlo Aortic Valve Dilatation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2025-03-11. The listed applicant is Disa Medinotec. The 510(k) number is K241562.

When did OutFlo Aortic Valve Dilatation Balloon Catheter receive FDA 510(k) clearance?

OutFlo Aortic Valve Dilatation Balloon Catheter received FDA 510(k) clearance on 2025-03-11, under 510(k) number K241562.

Who is the listed applicant for OutFlo Aortic Valve Dilatation Balloon Catheter?

The FDA 510(k) record lists Disa Medinotec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OutFlo Aortic Valve Dilatation Balloon Catheter?

The FDA product code for OutFlo Aortic Valve Dilatation Balloon Catheter is OZT.

其他以 Disa Medinotec 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。

K211894氣管導管器

相關器械（代碼：OZT）

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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