510(k) K153617 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Feb 25, 2016 |
| Received | Dec 18, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153617
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.