510(k) K973760 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
| Applicant | Avecor Cardiovascular, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 18, 1998 |
| Received | Oct 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973760
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.