FDA 510(k)

ARROW 压力注射式中线导管，具有 Chlorag+ard 抗菌和抗血栓形成技术

K 號：K161313 · 2016-08-24

申請人Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

決定日期2016-08-24

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 with Chlorag+ard Antimicrobial and Antithrombogenic Technology is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-08-24 under 510(k) number K161313. 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 with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K161313.

When did ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology receive FDA 510(k) clearance?

ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology received FDA 510(k) clearance on 2016-08-24, under 510(k) number K161313.

Who is the listed applicant for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

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

What is the FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology?

The FDA product code for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology is PND.

其他以 Arrow International, Inc. (Subsidiary of Teleflex, 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。

K180395EZ-IO 骨內血管通路系統 K163513Arrow Endurance Extended Dwell Peripheral Catheter System K160018Arrow Quickflash 动脈導管插入設備 K153487CG+ 飛箭 PICC，由飛箭 VPS Stylet PLUS 驅動 K153423CG+ 箭頭 JACC 驅動於 Arrow VPS Stylet，CG+ 箭頭 JACC

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.K213855Arrow 壓力注射中線針Arrow International, LLC Subsidiary of Teleflex Incorporated 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

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