FDA 510(k)

火箭 IPC 插入組，火箭 IPC 迷你插入組

K 號：K152105 · 2016-03-29

決定日期2016-03-29

產品代碼PNG

諮詢委員會GU

決定Unknown

器材摘要

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set 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 2016-03-29 under 510(k) number K152105. 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 IPC Insertion Set, Rocket IPC Mini Insertion Set?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Rocket Medical Plc. The 510(k) number is K152105.

When did Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set receive FDA 510(k) clearance?

Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set received FDA 510(k) clearance on 2016-03-29, under 510(k) number K152105.

Who is the listed applicant for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set?

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 IPC Insertion Set, Rocket IPC Mini Insertion Set?

The FDA product code for Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set is PNG.

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 K162457火箭內置腹膜導管（IPC）植入套件

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 Medical K221779ASEPT 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

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