FDA 510(k)

Arrow 壓力注射中線針

K 號：K213855 · 2022-09-02

申請人Arrow International, LLC Subsidiary of Teleflex Incorporated

決定日期2022-09-02

產品代碼PND

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Arrow Pressure Injectable Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K213855. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arrow Pressure Injectable Midline Catheter?

Arrow Pressure Injectable Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Arrow International, LLC Subsidiary of Teleflex Incorporated. The 510(k) number is K213855.

When did Arrow Pressure Injectable Midline Catheter receive FDA 510(k) clearance?

Arrow Pressure Injectable Midline Catheter received FDA 510(k) clearance on 2022-09-02, under 510(k) number K213855.

Who is the listed applicant for Arrow Pressure Injectable Midline Catheter?

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

What is the FDA product code for Arrow Pressure Injectable Midline Catheter?

The FDA product code for Arrow Pressure Injectable Midline Catheter is PND.

相關器械（代碼：PND）

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。

K252402中線心导管Terumo Medical Products (Hangzhou) Co., Ltd.K213203證誠™ 中間導管C.R. Bard, Inc.K210047斯提萊托延長停留式心臟导管Piper Access, LLC K192802primeMidline 靜脈針管Pfm Medical, Inc.K181208維瓊中線3F SL 腹腔鏈條導管；維瓊中線4F SL 腹腔鏈條導管；維瓊中線5F DL 腹腔鏈條導管Vygon USA K173114primeMidline 靜脈針管Pfm Medical, Inc.

官方來源

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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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：PND）

官方來源