510(k) K905008 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
FLEXIBLE INTRACARDIAC SUCTION DEVICE
| Applicant | Gish Biomedical, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jan 23, 1991 |
| Received | Nov 6, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905008
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.