FDA 510(k)

extriCARE® 3000 負壓治療系統

K 號：K221223 · 2023-02-09

決定日期2023-02-09

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

extriCARE® 3000 Negative Wound Pressure Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Alleva Medical Devices. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221223. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the extriCARE® 3000 Negative Wound Pressure Therapy System?

extriCARE® 3000 Negative Wound Pressure Therapy System is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Alleva Medical Devices. The 510(k) number is K221223.

When did extriCARE® 3000 Negative Wound Pressure Therapy System receive FDA 510(k) clearance?

extriCARE® 3000 Negative Wound Pressure Therapy System received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221223.

Who is the listed applicant for extriCARE® 3000 Negative Wound Pressure Therapy System?

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

What is the FDA product code for extriCARE® 3000 Negative Wound Pressure Therapy System?

The FDA product code for extriCARE® 3000 Negative Wound Pressure Therapy System is OMP.

其他以 Alleva Medical Devices 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。

K251646extriCARE® 1000 負壓創傷治療系統

相關器械（代碼：OMP）

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。

K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 負壓傷口治療系統Convatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 內容器 500-mL (CPC-500)Cork Medical K254019傷口基因NPWT系統Bechtel Medical, Inc.

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。