FDA 510(k)

Arrow 0.2 Micron Flat Filter, GVS

K 號：K222341 · 2023-02-13

決定日期2023-02-13

產品代碼CAZ

諮詢委員會AN

決定相當於

器材摘要

Arrow 0.2 Micron Flat Filter, GVS is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K222341. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arrow 0.2 Micron Flat Filter, GVS?

Arrow 0.2 Micron Flat Filter, GVS is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Arrow International, LLC. The 510(k) number is K222341.

When did Arrow 0.2 Micron Flat Filter, GVS receive FDA 510(k) clearance?

Arrow 0.2 Micron Flat Filter, GVS received FDA 510(k) clearance on 2023-02-13, under 510(k) number K222341.

Who is the listed applicant for Arrow 0.2 Micron Flat Filter, GVS?

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

What is the FDA product code for Arrow 0.2 Micron Flat Filter, GVS?

The FDA product code for Arrow 0.2 Micron Flat Filter, GVS is CAZ.

其他以 Arrow International, LLC 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。

K250542AC3™ 系列經主动脉氣囊泵 K232343AC3™ 系列IABP

相關器械（代碼：CAZ）

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。

K261372Profoject™ LOR 靜脈注射針CMT Health PTE., Ltd.K210983BD Epilor 静脈注射器Becton, Dickinson and Company K201356塑膠LOR針筒Jiangsu Caina Medical Co.,Ltd K202699E-Cath STIM 依照崔氏規範PAJUNK GmbH Medizintechnologie K190345VPCPAJUNK GmbH Medizintechnologie K161075Arrow硬脊膜外針套件Teleflexmedical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。