FDA 510(k)

Aspira 腹膜引流系統

K 號：K212675 · 2021-12-14

決定日期2021-12-14

產品代碼PNG

諮詢委員會GU

決定Unknown

器材摘要

Aspira Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212675. 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 Aspira Peritoneal Drainage System?

Aspira Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K212675.

When did Aspira Peritoneal Drainage System receive FDA 510(k) clearance?

Aspira Peritoneal Drainage System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212675.

Who is the listed applicant for Aspira Peritoneal Drainage System?

FDA 510(k) 記錄將 Merit Medical Systems, 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 Aspira Peritoneal Drainage System?

The FDA product code for Aspira Peritoneal Drainage System is PNG.

其他以 Merit Medical 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。

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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.K201155PleurX 腹膜導管系統Care Fusion K162457火箭內置腹膜導管（IPC）植入套件Rocket Medical Plc

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