510(k) K122878 ยท OBJ Catheter, Ultrasound, Intravascular
HD-IVUS ULTRASOUND IMAGING SYSTEM
| Applicant | Silicon Vally Medical Instruments, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jan 11, 2013 |
| Received | Sep 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122878
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.