510(k) K063740 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Jun 7, 2007 |
| Received | Dec 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063740
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2017 | KCI USA, INC. 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5).
The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound manage Terminated |
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 |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, In Terminated |
JCX | None listed |
| Sep 20, 2008 | KCI USA, Inc. 500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Terminated |
JCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.