Invia白色泡沫NPWT
K号: K180415 · 2018-11-02
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器械摘要
Invia White Foam NPWT is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180415. 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 Invia White Foam NPWT?
Invia White Foam NPWT is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Medela AG. The 510(k) number is K180415.
When did Invia White Foam NPWT receive FDA 510(k) clearance?
Invia White Foam NPWT received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180415.
Who is the listed applicant for Invia White Foam NPWT?
The FDA 510(k) record lists Medela AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Invia White Foam NPWT?
The FDA product code for Invia White Foam NPWT is OMP.
相关临床试验
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列明Medela AG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。
K251377Magic InBraK223388Invia®集成敷料K214112InviaEase负压伤口治疗（NPWT）系统K191653Freestyle FlexK182191Invia腹部敷料套装K172145Invia泡沫敷料套装带FitPad，InviaMotion负压伤口治疗系统（InviaMotion - Endure，InviaMotion – 120天，InviaMotion – 60天，InviaMotion – 30天，InviaMotion – 15天，InviaMotion – 7天），InviaLiberty负压伤口治疗系统，Invia纱布敷料套装带FitPad
相关器械（代码：OMP）
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。
K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 负压伤口治疗系统Convatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK254019伤口基因NPWT系统Bechtel Medical, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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