510(k) K021287 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 7, 2002 |
| Received | Apr 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2018 | Medtronic Perfusion Systems Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T
The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device desig Terminated |
DTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.