The following data is part of a premarket notification filed by Kci Usa, Inc. with the FDA for V.a.c. Rx4 Negative Pressure Wound Therapy (npwt) System.
| Device ID | K160487 |
| 510k Number | K160487 |
| Device Name: | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | KCI USA, Inc. 6203 Farinon Drive San Antonio, TX 78249 |
| Contact | Kristen Weniger Hopewell |
| Correspondent | Kristen Weniger Hopewell 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 | 2016-02-22 |
| Decision Date | 2016-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849554004740 | K160487 | 000 |