510(k) K183543 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
ACTIV.A.C. Therapy Unit
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Mar 20, 2019 |
| Received | Dec 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2020 | KCI USA, INC. ACTIV.A.C Therapy System; Model Numbers; US:
340000 ACTIV.A.C., NORTH AMERICAN
UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.