FDA 510(k)

Perifix FX 管針；Contiplex FX 管針

K 號：K231242 · 2023-09-15

決定日期2023-09-15

產品代碼BSO

諮詢委員會AN

決定相當於

器材摘要

Perifix FX Catheter; Contiplex FX Catheter 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 2023-09-15 under 510(k) number K231242. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Perifix FX Catheter; Contiplex FX Catheter?

Perifix FX Catheter; Contiplex FX Catheter is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K231242.

When did Perifix FX Catheter; Contiplex FX Catheter receive FDA 510(k) clearance?

Perifix FX Catheter; Contiplex FX Catheter received FDA 510(k) clearance on 2023-09-15, under 510(k) number K231242.

Who is the listed applicant for Perifix FX Catheter; Contiplex FX Catheter?

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 Perifix FX Catheter; Contiplex FX Catheter?

The FDA product code for Perifix FX Catheter; Contiplex FX Catheter is BSO.

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：BSO）

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。

K241410EDEN控制心臟导管Jmt Co., Ltd.K230603Arrow 非刺激型 SnapLock 适配器 (K-05520-005C)；Arrow 非刺激型 Next Gen SnapLock 适配器 (Luer 連接) (CA-000010-19)；Arrow 非刺激型 Next Gen SnapLock 适配器 (神經根連接) (CA-000014-19)；Arrow 刺激型 SnapLock 适配器 (帶電纜) (TZ-02060-001)；Arrow 刺激型 SnapLock 适配器 (帶卡扣) (TZ-05000-002)Teleflex Medical K193664SubQKath 穿刺針套組Hk Surgical K200624經皮導入器Epimed International, Inc.K191470C-CAT 麻醉針管組套Cimpax Aps K181782美林強化硬脊膜外針管Medline Industries, Inc.

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。