510(k) K130904 ยท QEY Mechanical Thrombolysis Catheter
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
| Applicant | Covidien, Mansfield MA, US |
| Decision | Substantially Equivalent, Oct 25, 2013 |
| Received | Apr 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, Terminated |
KRA | None listed |
| Feb 3, 2015 | Covidien Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and E Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.