FDA 510(k)

Actreen Mini 间歇性排尿導尿管

K 號：K151772 · 2016-02-09

決定日期2016-02-09

產品代碼GBM

諮詢委員會GU

決定相當於

器材摘要

Actreen Mini Intermittent Urinary Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K151772. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Actreen Mini Intermittent Urinary Catheters?

Actreen Mini Intermittent Urinary Catheters is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K151772.

When did Actreen Mini Intermittent Urinary Catheters receive FDA 510(k) clearance?

Actreen Mini Intermittent Urinary Catheters received FDA 510(k) clearance on 2016-02-09, under 510(k) number K151772.

Who is the listed applicant for Actreen Mini Intermittent Urinary Catheters?

FDA 510(k) 記錄將 B.Braun Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Actreen Mini Intermittent Urinary Catheters?

The FDA product code for Actreen Mini Intermittent Urinary Catheters is GBM.

其他以 B.Braun Medical, 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。

K254111灌洗/泌尿科套件 K253235Introcan Safety® 深層進入XL IV 腔管 K243392Infusomat® 空間體積輸液泵注射組 K240578VenaTech® LP 靜脈腔隔離器系統及 VenaTech® 可轉換型靜脈腔隔離器系統 K241845Introcan Safety® 2 靜脈針管 K241385Omnifix 靜脈注射針 NRFit

查看所有 35 項裝置 →

相關器械（代碼：GBM）

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。

K241734Wellead® 水性間歇性導尿管預先使用型；Wellead® 水性間歇性導尿管簡易型Well Lead Medical Co., Ltd.K213283GentleCath Air 男性水性間歇性尿道導尿管Convatec Limited K211436間斷導尿管（未定案）Hollister Incorporated K200820SpeediCath 簡易設備組Coloplast K192904SpeediCath 簡易設備組Coloplast K200142SpeediCath 軟體Coloplast

官方來源

在 FDA 資料庫中查看 →

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。