510(k) K003105 ยท DQO Catheter, Intravascular, Diagnostic
BIOSPHERE MEDICAL INFUSION CATHETER
| Applicant | Biosphere Medical, Rockland MA, US |
| Decision | Substantially Equivalent, May 22, 2001 |
| Received | Oct 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003105
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.