ASEPT® Glide 腹膜引流系統
K 號：K241278 · 2025-01-14
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器材摘要
ASEPT® Glide Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241278. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ASEPT® Glide Peritoneal Drainage System?
ASEPT® Glide Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K241278.
When did ASEPT® Glide Peritoneal Drainage System receive FDA 510(k) clearance?
ASEPT® Glide Peritoneal Drainage System received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241278.
Who is the listed applicant for ASEPT® Glide Peritoneal Drainage System?
The FDA 510(k) record lists Pfm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASEPT® Glide Peritoneal Drainage System?
The FDA product code for ASEPT® Glide Peritoneal Drainage System 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。
其他以 Pfm Medical, 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。
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。
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 FusionK162457火箭內置腹膜導管（IPC）植入套件Rocket Medical Plc
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。
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