510(k) K092361 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
| Applicant | Invatec S.P.A., Bethlehem PA, US |
| Decision | Substantially Equivalent, Oct 29, 2009 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092361
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.