510(k) K984271 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Mar 9, 1999 |
| Received | Nov 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984271
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.