510(k) K082646 ยท DQY Catheter, Percutaneous
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
| Applicant | Usci Ireland, North Reading MA, US |
| Decision | Substantially Equivalent, Nov 3, 2008 |
| Received | Sep 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082646
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.