510(k) K160514 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross 18, 30 MHz Peripheral Imaging Catheter
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Jun 22, 2016 |
| Received | Feb 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160514
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.