510(k) K161125 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross X, 40 MHz Coronary Imaging Catheter
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Apr 21, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161125
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.