FDA 510(k)

火箭置入式胸腔引流管（IPC）植入套件

K 號：K163321 · 2017-08-17

決定日期2017-08-17

產品代碼DWM

諮詢委員會履歷

決定相當於

器材摘要

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K163321. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Rocket Medical Plc. The 510(k) number is K163321.

When did Rocket Indwelling Pleural Catheter (IPC) Insertion Kit receive FDA 510(k) clearance?

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit received FDA 510(k) clearance on 2017-08-17, under 510(k) number K163321.

Who is the listed applicant for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

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

What is the FDA product code for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit?

The FDA product code for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit is DWM.

其他以 Rocket Medical Plc 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。

K210509Rocket Platinum 積層導管 K162457火箭內置腹膜導管（IPC）植入套件 K152105火箭 IPC 插入組，火箭 IPC 迷你插入組

相關器械（代碼：DWM）

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。

K212696Aspira 胸膜引流系統Merit Medical Systems, Inc.K210509Rocket Platinum 積層導管Rocket Medical Plc K201404Passio 泵排液系統Bearpac Medical K190292Passio 泵排液系統Bearpac Medical K160450Pleurx 胸腔針系統Care Fusion

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。