The following data is part of a premarket notification filed by Kci Usa, Inc. (kinetic Concepts, Inc.) with the FDA for V.a.c. Via Therapy System, V.a.c. Via Negative Pressure Therapy Unit, V.a.c. Via Dressing (containing V.a.c. Granufoam D.
| Device ID | K093526 |
| 510k Number | K093526 |
| Device Name: | V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, INC. (KINETIC CONCEPTS, INC.) 6203 FARINON DRIVE San Antonio, TX 78249 |
| Contact | Randall Wheeland |
| Correspondent | Randall Wheeland KCI USA, INC. (KINETIC CONCEPTS, 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 | 2009-11-16 |
| Decision Date | 2010-03-10 |
| Summary: | summary |