FDA 510(k)

BD Curve 腹水分流器

K 號：K170405 · 2017-11-02

決定日期2017-11-02

產品代碼KPM

諮詢委員會GU

決定Unknown

器材摘要

BD Curve Ascites Shunt is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K170405. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the BD Curve Ascites Shunt?

BD Curve Ascites Shunt is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is Care Fusion. The 510(k) number is K170405.

When did BD Curve Ascites Shunt receive FDA 510(k) clearance?

BD Curve Ascites Shunt received FDA 510(k) clearance on 2017-11-02, under 510(k) number K170405.

Who is the listed applicant for BD Curve Ascites Shunt?

The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Curve Ascites Shunt?

The FDA product code for BD Curve Ascites Shunt is KPM.

其他以 Care Fusion 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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查看所有 14 項裝置 →

相關器械（代碼：KPM）

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。

K231096自動持續滲出分流器系統 (ACES) 系統 ACES 系統Pleural Dynamics, Inc.

官方來源

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