FDA 510(k)

LimFlow向量

K 號：K260188 · 2026-03-18

決定日期2026-03-18

產品代碼MGZ

諮詢委員會履歷

決定相當於

器材摘要

LimFlow Vector is the device name listed in this FDA 510(k) record. The listed applicant is LimFlow, Inc.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K260188. 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 LimFlow Vector?

LimFlow Vector is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is LimFlow, Inc.. The 510(k) number is K260188.

When did LimFlow Vector receive FDA 510(k) clearance?

LimFlow Vector received FDA 510(k) clearance on 2026-03-18, under 510(k) number K260188.

Who is the listed applicant for LimFlow Vector?

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

What is the FDA product code for LimFlow Vector?

The FDA product code for LimFlow Vector is MGZ.

其他以 LimFlow, Inc. 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。

K251376LimFlow ARC K242776LimFlow V-Ceiver K221902LimFlow向量 K221541LimFlow ARC K222083LimFlow V-Ceiver

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。

K250105回旋瓣膜刀（BMGVT080）；回旋推瓣膜刀（BMGPVT125）Aveera Medical, Inc.K221902LimFlow向量LimFlow, Inc.K190267EZE SIT 過濾刀Lemaitre Vascular

官方來源

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