510(k) K143016 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
| Applicant | Cardinalhealth, Waukegan IL, US |
| Decision | Substantially Equivalent, Apr 20, 2015 |
| Received | Oct 20, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143016
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2020 | Cardinal Health 200, LLC Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage:
The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-th Terminated |
OMP | None listed |
| Jun 4, 2020 | Cardinal Health 200, LLC Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.