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FDA 510(k)

火箭內置腹膜導管（IPC）植入套件

K 號：K162457 · 2016-11-14

申請人Rocket Medical Plc
決定日期2016-11-14
產品代碼PNG
諮詢委員會GU
決定Unknown

器材摘要

Rocket Indwelling Peritoneal 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 2016-11-14 under 510(k) number K162457. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

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

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is a medical device that received FDA 510(k) clearance on 2016-11-14. The listed applicant is Rocket Medical Plc. The 510(k) number is K162457.

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

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit received FDA 510(k) clearance on 2016-11-14, under 510(k) number K162457.

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

The FDA product code for Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is PNG.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K163321火箭置入式胸腔引流管（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：PNG）

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。

K241278ASEPT® Glide 腹膜引流系統Pfm Medical, Inc.K241946PeritX™ 1L 排液套件 (90-1010)；PeritX™ 2L 排液套件 (90-2010)；PeritX™ 腹膜導管套件 (50-9000C)；PeritX™ 腹膜導管及開始套件 (50-9900C)；PeritX™ 腹膜導管迷你套件 (50-9050A)；PleurX™ 低外型導管迷你套件 (50-8050)；閥門蓋 (50-7235A)；PeritX™ 閥門套件 (50-7272)；導管進入套件 (50-7280A)；可鎖定排液管 (50-7245A)；可鎖定排液管套件 (50-7265A)；PleurX™ 补充植入套件 (50-7262)；手術包 (50-)Bard Peripheral Vascular, Inc.K230319Passio 泵排液系統Bearpac MedicalK221779ASEPT 腹膜引流系統Pfm Medical, Inc.K212675Aspira 腹膜引流系統Merit Medical Systems, Inc.K201155PleurX 腹膜導管系統Care Fusion

官方來源

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