FDA 510(k)

美敦力生物醫學成人針管套件

K 號：K153598 · 2016-01-15

決定日期2016-01-15

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Medtronic Bio-Medicus Adult Cannula Kit is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K153598. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medtronic Bio-Medicus Adult Cannula Kit?

Medtronic Bio-Medicus Adult Cannula Kit is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K153598.

When did Medtronic Bio-Medicus Adult Cannula Kit receive FDA 510(k) clearance?

Medtronic Bio-Medicus Adult Cannula Kit received FDA 510(k) clearance on 2016-01-15, under 510(k) number K153598.

Who is the listed applicant for Medtronic Bio-Medicus Adult Cannula Kit?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Medtronic Bio-Medicus Adult Cannula Kit?

The FDA product code for Medtronic Bio-Medicus Adult Cannula Kit is DWF.

其他以 Medtronic, 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。

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相關器械（代碼：DWF）

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。

K260195延長式單件動脈（EOPA）3D™ 運動脈管Medtronic, Inc.K250937靜脈回流針管LivaNova USA, Inc.K260043智能反應器迷彩塗層循環離身心肺管路組（SR180C）Smart Reactors K253203後向冠狀動脈 sinus 灌注針管Medtronic, Inc.K253671雙階段靜脈針管Sorin Group Italia S.R.L.K253998清晰視內冠狀動脈分流器Medtronic, Inc.

官方來源

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