510(k) K173284 ยท OBJ Catheter, Ultrasound, Intravascular
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | Oct 16, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173284
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.