510(k) K062227 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
V.A.C. THERAPY SYSTEM
| Applicant | Kci USA, Inc. (Kinetic Concepts, Inc.), San Antonio TX, US |
| Decision | Substantially Equivalent, Oct 4, 2006 |
| Received | Aug 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2025 | KCI USA, INC. 3M V.A.C. VIA Negative Pressure Wound Therapy System
REF:
VIAKIT077D01/US - V.A.C. VIA 7 Day Kit
VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack
VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper Open, Classified |
OMP | None listed |
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268882 used with InfoVAC Model M825999,, InvoVac Canadian Model M8260027, and Vac ATS Model 825 Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.