510(k) K031700 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 29, 2003 |
| Received | Jun 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas exchange device for Cardiopulmonary Bypass. Catalog Number: 71166 Terminated |
DTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.