510(k) K961530 ยท DTZ Oxygenator, Cardiopulmonary Bypass
GISH RELIANCE OXYGENATOR (MODEL HFO)
| Applicant | Gish Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 5, 1996 |
| Received | Apr 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2003 | Gish Biomedical Inc Vision Hollow Fiber Oxygenator Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.