FDA 510(k)

PowerLoc™ Max 電漿注射輸液套組；SafeStep™ Huber 鋒針套組

K 號：K241353 · 2024-11-27

決定日期2024-11-27

產品代碼PTI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241353. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K241353.

When did PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set receive FDA 510(k) clearance?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241353.

Who is the listed applicant for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is PTI.

其他以 Bard Access Systems, 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。

K252478Vaccess™ CT 低輪廓電漿注射式植入式港道；Vaccess™ CT 電漿注射式植入式港道；PowerPort™ duo M.R.I.™ 植入式港道 K251253PowerPort™ 嵌入式港；PowerPort™ 縮小嵌入式港；PowerPort™ M.R.I.™ 嵌入式港；PowerPort™ M.R.I.™ isp 嵌入式港 K242328PowerPort™ ClearVUE™ 瘦型植入式港道及PowerPort™ ClearVUE™ 瘦型植入式港道 K240146BD Prevue™ II 頸外周血管通路系統 K222232Sherlock 3CG® 結構定位系統 (TPS) 鋒針/T-Lock 製件 K210264BD PowerPiCC 線管

查看所有 7 項裝置 →

相關器械（代碼：PTI）

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。

K25409525G 胡伯針Martech Medical Products K252355K-SHIELD Advantage PORT ACCESS 灌注設備高壓管路Sb-Kawasumi Laboratories, Inc.K251138Promisemed 安全中心 Huber 靈敏針Promisemed Hangzhou Meditech Co., Ltd.K243332Promisemed 安全中心 Huber 靈敏針Promisemed Hangzhou Meditech Co., Ltd.K230715Promisemed 安全中心 Huber 针Promisemed Hangzhou Meditech Co., Ltd.K213823Intera 填充套件Intera Oncology, 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。