FDA 510(k)

Prevena Plus 切口管理系統，Prevena Plus Duo 切口管理系統

K 號：K180855 · 2018-06-01

決定日期2018-06-01

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

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180855. 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 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System?

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Kci USA, Inc.. The 510(k) number is K180855.

When did Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System receive FDA 510(k) clearance?

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180855.

Who is the listed applicant for Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System?

The FDA 510(k) record lists Kci USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System?

The FDA product code for Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System is OMP.

其他以 Kci USA, 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。

K2411343M® ActiV.A.C.® 罐 - 300ml 含凝胶 (M8275058/5, M8275058/10)K201571ACTIV.A.C. 负壓創傷治療系統 K200390V.A.C. 皮膚科用覆蓋布 K190697PREVENA PLUS 切口管理系統（無抗生素）；PREVENA PLUS DUO 切口管理系統（無抗生素）K181505V.A.C. 皮膚科用覆蓋布 K183543ACTIV.A.C. 治療單元

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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

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