510(k) K992910 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Sep 15, 1999 |
| Received | Aug 30, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992910
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.