The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c.via 7 Day Therapy System Kit, V.a.c.via Therapy Starter Kit, V.a.c.via Negative Pressure Wound Therapy Unit.
Device ID | K173447 |
510k Number | K173447 |
Device Name: | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
Contact | Melanie Avila |
Correspondent | Melanie Avila KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-06 |
Decision Date | 2018-03-02 |
Summary: | summary |