510(k) K032310 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
| Applicant | Kinetic Concepts, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Oct 10, 2003 |
| Received | Jul 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2006 | Kinetic Concepts, Inc V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE. Terminated |
JCX | None listed |
| Oct 22, 2004 | Kinetic Concepts, Inc V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230 Terminated |
JCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.