FDA 510(k)

PREVENA PLUS 切口管理系统，PREVENA PLUS DUO 切口管理系统

K号: K173426 · 2018-03-09

决定日期2018-03-09

产品代码OMP

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决定实质等同

器械摘要

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 2018-03-09 under 510(k) number K173426. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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 2018-03-09. The listed applicant is Kci USA, Inc.. The 510(k) number is K173426.

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 2018-03-09, under 510(k) number K173426.

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.

列明Kci USA, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K2411343M™ ActiV.A.C.™ 罐 - 300ml 配凝胶 (M8275058/5, M8275058/10)K201571ACTIV.A.C. 负压伤口治疗系统 K200390V.A.C. DERMATAC 遮盖物 K190697PREVENA PLUS 切口管理系统（无银）；PREVENA PLUS DUO 切口管理系统（无银）K181505V.A.C. DERMATAC 遮盖物 K183543ACTIV.A.C. 治疗单元

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