510(k) K003145 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
ORIGEN BLADDER HOLDER
| Applicant | Origen Biomedical, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Apr 20, 2001 |
| Received | Oct 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003145
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.