510(k) K113008 ยท OBJ Catheter, Ultrasound, Intravascular
KODAMA INTRAVASCULAR ULRASOUND CATHETER
| Applicant | Silicon Vally Medical Instruments, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jun 14, 2012 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113008
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.