FDA 510(k)

FLASH Flex™ 頸動脈-近端動脈成形術系統

K 號：K254022 · 2026-04-02

決定日期2026-04-02

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

FLASH Flex™ Aorto-Ostial Angioplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Verge Medical, Inc.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K254022. 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 FLASH Flex™ Aorto-Ostial Angioplasty System?

FLASH Flex™ Aorto-Ostial Angioplasty System is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Verge Medical, Inc.. The 510(k) number is K254022.

When did FLASH Flex™ Aorto-Ostial Angioplasty System receive FDA 510(k) clearance?

FLASH Flex™ Aorto-Ostial Angioplasty System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K254022.

Who is the listed applicant for FLASH Flex™ Aorto-Ostial Angioplasty System?

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

What is the FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System?

The FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System is LOX.

其他以 Verge Medical, Inc. 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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