510(k) K003288 ยท DQO Catheter, Intravascular, Diagnostic
ORIGEN DUAL LUMEN CATHETER
| Applicant | Origen Biomedical, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | Oct 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003288
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.