510(k) DEN180013
- Device
- PREVENA 125 and PREVENA PLUS 125 Therapy Units
- Applicant
- Kci USA, Inc.
- 510(k) number
- DEN180013
- Product code
- QFC
- Decision
- Unknown (DENG)
- Decision date
- 2019-04-19
- Date received
- 2018-03-15
- Regulation
- 878.4783
- Classification name
- Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kimberly McCoy
- Address
- 6203 Farinon Dr. San Antonio TX US 78249 78249
FDA Registration Numbers#
- 3014209526
- 3012358417
- 3006808392
- 3010173425
- 3005178245
- 3010223109
- 8043484
- 3008132398
- 3009897021
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QFC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023-02-13 |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Smith and Nephew Medical Limited | 2021-12-14 |