510(k) K000430 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Feb 25, 2000 |
| Received | Feb 9, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000430
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4. Terminated |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.