510(k) K080708 ยท DTZ Oxygenator, Cardiopulmonary Bypass
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Feb 2, 2009 |
| Received | Mar 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080708
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.