FDA 510(k)

V.A.C. Rx4 负压伤口治疗（NPWT）系统

K号: K160487 · 2016-12-09

决定日期2016-12-09

产品代码OMP

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决定实质等同

器械摘要

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) 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 2016-12-09 under 510(k) number K160487. 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 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Kci USA, Inc.. The 510(k) number is K160487.

When did V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2016-12-09, under 510(k) number K160487.

Who is the listed applicant for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) 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 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) 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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官方来源

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