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FDA 510(k)

回旋瓣膜刀(BMGVT080);回旋推瓣膜刀(BMGPVT125)

K 號:K250105 · 2025-07-03

決定日期2025-07-03
產品代碼MGZ
諮詢委員會履歷
決定相當於

器材摘要

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is the device name listed in this FDA 510(k) record. The listed applicant is Aveera Medical, Inc.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250105. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Aveera Medical, Inc.. The 510(k) number is K250105.

When did Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) receive FDA 510(k) clearance?

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250105.

Who is the listed applicant for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

The FDA 510(k) record lists Aveera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

The FDA product code for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is MGZ.

相關臨床試驗

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相關器械(代碼:MGZ)

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。

官方來源

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