510(k) K936003 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
AFFINITY CVR
| Applicant | Avecor Cardiovascular, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 20, 1994 |
| Received | Dec 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2018 | Medtronic Perfusion Systems Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540
The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood Terminated |
DTN | None listed |
| Jan 26, 2008 | Medtronic Perfusion Systems Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604. Terminated |
DTZ | None listed |
| Jul 20, 2004 | Medtronic Perfusion Systems Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.