510(k) K162790 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
V.A.C.ULTA Negative Pressure Wound Therapy System
| Applicant | Kci USA, Inc. (Kinetic Concepts, Inc.), San Antonio TX, US |
| Decision | Substantially Equivalent, Jan 26, 2017 |
| Received | Oct 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162790
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2024 | KCI USA, INC. V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01
The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an
integrated wound management system that provides Negative Pressure
Wound Therapy w Open, Classified |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.