510(k) K150573 ยท OQY Intrauterine Tamponade Balloon
ebb Complete Tamponade System
| Applicant | Clinical Innovations, LLC, Murray UT, US |
| Decision | Substantially Equivalent, Mar 25, 2015 |
| Received | Mar 6, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150573
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2015 | Clinical Innovations, LLC The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY.
Intended for use in providing temporary control or reduction of postpartum uterine bleeding. Terminated |
OQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.