FDA 510(k)

LimFlow ARC

K 號：K221541 · 2022-08-31

決定日期2022-08-31

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

LimFlow ARC is the device name listed in this FDA 510(k) record. The listed applicant is LimFlow, Inc.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221541. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LimFlow ARC?

LimFlow ARC is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is LimFlow, Inc.. The 510(k) number is K221541.

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

LimFlow ARC received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221541.

Who is the listed applicant for LimFlow ARC?

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 ARC?

The FDA product code for LimFlow ARC is PDU.

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。

K260188LimFlow向量 K251376LimFlow ARC K242776LimFlow V-Ceiver K221902LimFlow向量 K222083LimFlow V-Ceiver

相關器械（代碼：PDU）

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。

K262013奇巴CTO橫越導管Reflow Medical, Inc.K252315Santreva™-ATK內血管再血管化針筒AngioSafe, Inc.K251158PowerWire® 14 電波導絲套件Baylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire 電波頻率導絲套件Baylis Medical Technologies, Inc.K230159SoundBite® 穿刺系統 XS 外周Soundbite Medical Solutions, Inc.

官方來源

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