FDA 510(k)

Arrow Quickflash 动脈導管插入設備

K 號：K160018 · 2016-06-13

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

決定日期2016-06-13

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Arrow Quickflash Arterial Catheterization Device 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 2016-06-13 under 510(k) number K160018. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arrow Quickflash Arterial Catheterization Device?

Arrow Quickflash Arterial Catheterization Device is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The 510(k) number is K160018.

When did Arrow Quickflash Arterial Catheterization Device receive FDA 510(k) clearance?

Arrow Quickflash Arterial Catheterization Device received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160018.

Who is the listed applicant for Arrow Quickflash Arterial Catheterization Device?

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 Quickflash Arterial Catheterization Device?

The FDA product code for Arrow Quickflash Arterial Catheterization Device is DQX.

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 K161313ARROW 压力注射式中线导管，具有 Chlorag+ard 抗菌和抗血栓形成技术 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：DQX）

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。

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